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Developing and implementing a randomized pilot study of an occupation-based diabetes management intervention
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Developing and implementing a randomized pilot study of an occupation-based diabetes management intervention
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Content
DEVELOPING AND IMPLEMENTING A RANDOMIZED PILOT STUDY OF AN
OCCUPATION-BASED DIABETES MANAGEMENT INTERVENTION
by
Elizabeth Pyatak, PhD, OTR/L, CDE
A Thesis Presented to the
FACULTY OF THE USC KECK SCHOOL OF MEDICINE
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF SCIENCE
(CLINICAL AND BIOMEDICAL INVESTIGATIONS)
December 2015
Copyright 2015 Elizabeth Pyatak
Table of Contents
List of Tables 3
Abbreviations 4
Introduction and Preface 7
Chapter 1: Developing a manualized occupational therapy diabetes management
intervention: Resilient, Empowered, Active Living with Diabetes 9
Chapter 2: K01 Grant Application Specific Aims and Research Strategy 27
Chapter 3: Manual of Operations and Procedures for the REAL: Resilient,
Empowered, Active Living with Diabetes Intervention 54
References 119
3
List of Tables
p. 14 Figure 1.1 Overview of intervention manual development
p. 18 Figure 1.2. Core intervention principles for REAL intervention
p. 21 Table 1.1. Overview of intervention manual contents
p. 38 Table 2.1. Proof-of-concept study outcomes
p. 39 Table 2.2. Study entry criteria
p. 41 Table 2.3. Timeline of planned research activities
p. 46 Table 2.4. Overview of REAL intervention content
p. 49 Table 2.5. Measures of primary and secondary outcomes, and potential mediators
p. 72 Table 3.1 Recruitment criteria
p. 78 Figure 3.1 Study flow diagram
p. 79 Figure 3.2 Screening and enrollment process
p. 88 Table 3.3. Timeline and visit schedule
p. 98 Table 3.4. List of REAL Study forms
p. 116 Table 3.5. Protocol deviation log
p 118 Table 3.6. MOP modification log
4
Abbreviations
A1C: glycated hemoglobin (blood glucose level over the past two to three months)
AADE: American Association of Diabetes Educators
ADD-QoL: Audit of Diabetes-Dependent Quality of Life
ADL: Activity of daily living
CCS: California Children’s Services
CDC: Centers for Disease Control and Prevention
CHP: Center for Health Professions
CITI: Collaborative IRB Training Initiative
CLIA: Clinical Laboratory Improvement Amendments
CSV: Comma Separated File
DES-SF: Diabetes Empowerment Scale-Short Form
DKQ: Diabetes Knowledge Questionnaire
DOB: date of birth
DPSI: Diabetes Problem-Solving Interview
DSMC: Data and Safety Monitoring Committee
EBT: Electronic bank transfer
GCP: Good Clinical Practice
HIPAA: Health Insurance Portability and Accountability Act
ID: Identification
IRB: Institutional Review Board
LA: Los Angeles
LAC+USC: Los Angeles County + University of Southern California
5
MeSH: Medical Sub Heading
MOP: Manual of Procedures
MRUN: Medical Record Identification Number
NIH: National Institutes of Health
NCATS: National Center for Advancing Translational Sciences
NCBDE: National Certification Board for Diabetes Educators
NIDDK: National Institute of Diabetes, Digestive and Kidney Disorders
OPRS: Office for the Protection of Research Subjects
ORSA: Outpatient Reduced-Fee Simplified Application
OSHA: Occupational Safety and Health Administration
OT: Occupational Therapy/Occupational Therapist
OTJR: Occupational Therapy Journal of Research
OTR/L: Occupational therapist (registered/licensed)
PAID: Problem Areas in Diabetes
PHQ-9: Patient Health Questionnaire-9
PI: Principal Investigator
PM: Preventive Medicine
POPS: Participation Objective, Participation Subjective
RA: Research Assistant
RCT: Randomized controlled trial
REAL: Resilient, Empowered, Active Living
SD: standard deviation
SDSCA: Summary of Diabetes Self-Care Activities
6
SSN: Social Security Number
SWLS: Satisfaction with Life Scale
T1D: Type 1 diabetes
T2D: Type 2 diabetes
TODAY: Treatment Options for Type 2 Diabetes in Adolescents and Youth
WIC: Special Supplemental Nutrition Program for Women, Infants and Children
YA: Young adult
7
Introduction and Preface
This thesis presents an overview of the initial phases of an ongoing research program, the
aim of which has been to develop and evaluate a diabetes management intervention tailored to
address the health and quality of life needs of young adults with either type 1 or type 2 diabetes.
This program of research was initially funded through an NIH/NCATS KL2 award, and
subsequently through an NIH/NIDDK K01 award. This thesis presents research completed
during the KL2 award, including the development and manualization of the REAL (Resilient,
Empowered, Active Living with Diabetes) intervention, development and submission of a K01
grant application, and developing a Manual of Procedures (MOP) for the study subsequently
funded by the K01 award.
Chapter 1 is a manuscript describing the development of the REAL intervention,
published in OTJR: Occupation, Participation, and Health. This paper describes work that was
completed during the second year of the KL2 program, during which the findings of the
aforementioned needs assessment were translated into intervention principles, goals, and
activities and compiled into an intervention manual. Subsequently, a proof-of-concept study was
carried out to evaluate provisional feasibility of the intervention, and necessary manual revisions
for a larger-scale pilot study.
Chapter 2 is the Specific Aims and Research Plan of a K01 grant application which was
funded in July 2014. This grant proposal was initially developed during the three-course Clinical
and Translational Research series (PM 599a, 599b, and 599c) during the first year of the KL2
program and submitted to NIH in October 2012. Following its review and scoring, it was revised
and re-submitted in November 2013, and subsequently selected for funding. The K01 Specific
8
Aims and Research Plan outline the rationale and research strategy for the pilot randomized trial
of the REAL Intervention, which is currently in Year 2 (of 3) of funding.
Chapter 3 is the initial Manual of Procedures (MOP) developed to guide implementation
of the pilot randomized trial evaluating the REAL Intervention. The MOP outlines best practices
and procedures for the study, and was modeled after a sample MOP template published by the
National Institute for Complementary and Alternative Medicine (now National Center for
Complementary and Integrative Health). As a living document, this MOP has undergone
subsequent revisions as the REAL Intervention study has been underway. In addition, some
names and contact information for students and staff working on the REAL study have been
redacted for privacy considerations.
9
Chapter 1: Developing a manualized occupational therapy diabetes
management intervention: Resilient, Empowered, Active Living with Diabetes
Abstract
This paper reports on the development of a manualized occupational therapy intervention for
diabetes management. An initial theoretical framework and core content areas for a Stage 1
intervention manual were developed based on an in-depth needs assessment and review of
existing literature. After evaluation by a panel of experts and completion of a feasibility study,
the intervention was revised into a Stage 2 manual in preparation for a randomized study
evaluating the intervention’s efficacy. In developing the initial manual, we delineated core
theoretical principles to allow for flexible application and tailoring of the intervention’s content
areas. Expert panel feedback and feasibility study results led to changes to the intervention
structure and content as we developed the Stage 2 manual. Through describing this process, we
illustrate the dynamic evolution of intervention manuals, which undergo revisions due to both
theoretical and practical considerations at each stage of the research-to-clinical practice pipeline.
MeSH Keywords: feasibility studies; disease management; self care
10
In the current healthcare climate, which demands empirical evidence to support clinical
practice, there has been a distinct movement toward enhancing the replicability of therapeutic
interventions through the use of manuals, protocols and other strategies to maintain intervention
fidelity (Murphy & Gutman, 2012). Blanche et al. (2011) argued that an “urgent need exists for
occupational therapy researchers and practitioners to understand the role of manualized
interventions in [research and] clinical practice” (p. 712). While treatment manuals and other
fidelity-monitoring strategies create a reproducible structure for intervention implementation,
they have also been critiqued as minimizing the role of clinical reasoning, inhibiting therapist
empathy, being inflexible, and being limited in their theoretical basis, which does not reflect the
eclectic use of multiple theoretical frameworks in clinical practice (Blanche et al., 2011;
Cukrowicz, Timmons, Sawyer, Caron, Gummelt, & Joiner, 2011; Waller, Mountford, Tatham,
Turner, Gabriel, & Webber, 2013). Additionally, there is not yet unequivocal evidence regarding
the efficacy of manualized interventions; while many studies have shown superior therapeutic
outcomes using manualized interventions as compared to non-manualized interventions (e.g.,
Cukrowicz et al., 2011; Robbins et al., 2011; Rossouw & Fonagy, 2012), others have found
similar effects in manualized versus non-manualized interventions (e.g., Horigian et al., 2013).
Despite these potential limitations, intervention manuals remain necessary as a means to
facilitate rigorous and systematic evaluation of therapeutic interventions, thereby providing
evidence to justify our treatments to third-party payers and other stakeholders (Murphy &
Gutman, 2013). Additionally, they are a useful tool to translate effective intervention strategies
across practice settings. As such, our challenge is to identify strategies to ameliorate the potential
limitations of manualized interventions with respect to flexibility and therapeutic use of self.
11
A critical function of treatment manuals is to facilitate the translation of interventions
from research into clinical practice. One model of manual development, outlined by Carroll and
Nuro (2002), details the structure and function of treatment manuals at each stage of this research
to practice intervention pipeline. Their approach recognizes that, while all treatment manuals
should incorporate certain elements (such as intervention content, mode of delivery, dose, and
setting of the intervention; Des Jarlais, Lyles, Crepaz, & TREND Group, 2004), a manual’s level
of complexity evolves through various stages of the research process, with each stage
incorporating greater complexity and a more explicit framework to guide clinical practice. Stage
1 manuals provide an initial specification of intervention techniques, goals, structure, format, and
theoretical mechanisms, to guide pilot and feasibility studies. Stage 2 manuals, used in large-
scale efficacy studies, add therapist selection, training, and supervision criteria; differences
between the manualized intervention and other approaches; and processes to evaluate
intervention fidelity. Stage 3 manuals, used to disseminate interventions shown to be successful
in research settings into clinical practice, include all of the above, as well as strategies to tailor
the intervention for different patient groups, settings, and formats.
In this paper, we report on the process of developing a manualized occupational therapy
intervention addressing diabetes management in young adults. We will describe our strategies for
drafting a Stage 1 manual, implementing a feasibility study, and refining the intervention in a
Stage 2 manual in preparation for a randomized study to evaluate the efficacy of the intervention.
In describing this process, we aim to share with other clinicians and researchers our methods for
developing intervention materials and strategies for addressing the potential drawbacks inherent
to manualized interventions (such as a lack of flexibility and inattention to the client-therapist
relationship).
12
At its outset, the intervention we describe was conceptualized as an iteration of the
occupational therapy intervention approach known as Lifestyle Redesign. This approach,
previously employed in two large-scale research programs, the Well Elderly and Pressure Ulcer
Prevention Studies (Clark et al., 1997; Clark et al., 2012; Clark et al., 2014), also serves as the
overarching intervention framework for an outpatient occupational therapy practice at the
University of Southern California (USC Occupational Therapy Faculty Practice, n.d.). Lifestyle
Redesign is characterized by three primary features. First, occupation is conceptualized as an
emergent phenomenon: it cannot be fully understood by analyzing its individual elements (e.g.
physical and cognitive requirements, physical environment and sociocultural context) in a
reductionist manner. Second, life history and personal themes of meaning, or the ways people
understand and make sense of their lives, are incorporated into intervention goals and strategies,
such that occupations that are most meaningful and relevant within a particular client’s life
context are used therapeutically in the intervention. Finally, the intervention teaches occupational
self-analysis, through providing clients with tools to examine their lifestyles and integrate
sustainable, health-promoting changes into their everyday habits and routines (Jackson, Carlson,
Mandel, Zemke, & Clark, 1998). The intervention we developed, called REAL: Resilient,
Empowered, Active Living with Diabetes, was informed by these principles, research on
efficacious diabetes self-management strategies, and our findings of an in-depth needs
assessment among the target population (Pyatak, Florindez, Peters, & Weigensberg, 2014;
Pyatak, Florindez, & Weigensberg, 2013; Pyatak, Sequeira, et al., 2014).
Methods
A timeline of all manual development activities is provided in Figure 1.1 (shown on Page
14). Below, we detail the methods used for developing the Stage 1 manual, conducting a
13
feasibility study, and completing revisions to create a Stage 2 manual for use in a randomized
efficacy study.
Stage 1 Manual Development
Stage 1 intervention manual development incorporated three steps. First, we outlined a
preliminary theoretical framework and intervention modules (content areas). The theoretical
framework was developed through E.A.P’s review of relevant health behavior theories, including
Social Cognitive Theory (Bandura, 1988), Self-Determination Theory (Ryan & Deci, 2000), and
the Transtheoretical Model (Prochaska, DiClemente & Norcross, 1992), as well as interviews
with four clinicians with experience implementing Lifestyle Redesign interventions. These
clinicians had between 5 and 36 years of experience in a range of practice settings including
pediatric and adult physical rehabilitation, wellness and prevention, and chronic disease
management. The content modules were informed by an extensive needs assessment conducted
among the target population, the findings of which are outlined in (Pyatak, Florindez, et al. 2014;
Pyatak, Florindez, et al., 2013; Pyatak, Sequeira, et al., 2014), and by E.A.P.’s review of existing
interventions including previous Lifestyle Redesign interventions (Jackson et al., 1998; Blanche
et al., 2011) and the Stanford University Chronic Disease Self-Management Program and
Diabetes Self-Management Program, two highly successful and widely-disseminated manualized
self-management interventions (Lorig et al., 1999; Lorig, Ritter, Villa, & Armas, 2009). An
occupational therapy doctoral student (S.D.) then developed drafts of the theoretical framework
and intervention modules, which were revised in an iterative process with feedback from E.A.P.
Next, the preliminary manual was reviewed during two focus groups, lasting
approximately two hours each. A total of nine experts participated in the focus groups, including
14
Figure 1.1. Overview of Intervention Manual Development
15
a pediatric and an adult endocrinologist; a health behavior researcher; a dietician; and five
occupational therapists with experience delivering Lifestyle Redesign interventions with a
variety of populations. Two of the above-identified experts were also certified diabetes
educators
®
. The sessions were led by E.A.P. and S.D. Focus group participants were asked for
their input regarding the theoretical framework; the intervention’s structure and delivery (e.g.,
dose, frequency, setting); the planned assessment and goal-setting procedures; and the module
content (including suggested goals and activities, participant handouts and resources, and
therapist resources). A graduate research assistant took detailed notes during the meetings, which
were also audio recorded for later review. The research team, including E.A.P., S.D., a graduate
research assistant, and two senior faculty mentors (one endocrinologist and one occupational
therapist) subsequently reviewed these notes, categorized suggested revisions, and determined
which to incorporate into the intervention. The major revisions at this stage included refining the
study’s assessment tools; incorporating an iPad as an intervention resource to facilitate accessing
websites and YouTube videos; and augmenting the intervention modules with information on
specific content areas, such as diabetes and driving, how to utilize health insurance benefits, and
emotional eating.
Feasibility Study
After completing the Phase 1 manual, a feasibility study was conducted to address the
following aims: (1) evaluate the planned recruitment, assessment, and intervention procedures;
and (2) evaluate the feasibility and acceptability of the intervention from the perspective of both
the therapist and participants. The methods and results of the feasibility study are being reported
in detail elsewhere. In brief, eight participants ages 18-30, who had been diagnosed with either
type 1 or type 2 diabetes for at least one year, were offered weekly occupational therapy sessions
16
(median of 8 sessions; range: 7-12) over approximately 2 months guided by the Stage 1 manual.
Because the target population was known to have poor clinic attendance, sessions were provided
in participants’ homes or community settings. Participants completed pre- and post-intervention
assessments, and were interviewed following study completion to solicit their views of the
intervention and study procedures. The feasibility study was approved by the university’s
Institutional Review Board, and all participants completed informed consent prior to engaging in
study activities.
Stage 2 Manual Revisions
Following the feasibility study, further revisions were made to the intervention manual,
based on three data sources: (1) interviews conducted with study participants and the treating
occupational therapist; (2) treatment notes made by the occupational therapist; and (3) a log of
potential revisions maintained by the research team during feasibility study implementation.
Post-intervention interviews were transcribed verbatim and entered into NVivo 10 for
thematic analysis (Riessman, 2008). The coded data, along with the therapist’s treatment notes
and the log of suggested revisions, were reviewed by the research team. A list of potential
revisions was generated, and through discussion, the team came to consensus regarding a final
set of revisions to make in the Stage 2 intervention manual. In addition to these changes, we
incorporated elements into the Stage 2 manual that are not specified in a Stage 1 manual.
Results
Stage 1 Manual Development
As previously stated, the primary aims of a Stage 1 manual are the initial specification of
techniques, goals, structure, format, and theoretical mechanisms of an intervention (Carroll &
Nuro, 2002). In developing the Stage 1 REAL treatment manual, we aimed to address these goals
17
while balancing the need for a well-characterized intervention with the flexibility that
characterizes clinical practice. We adopted two strategies to address this challenge. First, the
intervention’s theoretical framework was informed by a set of core principles derived from
multiple theoretical perspectives, rather than a single theoretical lens. Second, the intervention’s
structure and content were designed to be individually tailored: for example, therapists can
modify the duration and frequency of sessions for each client, and do not need to deliver
intervention content in a prescribed order. The intervention framework, structure, and content, as
conceptualized in the Stage 1 manual, are described below.
REAL intervention framework. The core principles of the REAL intervention, along
with clinical examples of their application in the feasibility study, are presented in Figure 1.2.
We view these principles as creating the overarching theoretical framework of the intervention,
which represents an adaptation of the original Lifestyle Redesign intervention approach. In
crafting these principles that draw upon multiple theories, rather than basing the intervention on
a singular theory, our aim was to develop a rich, yet flexible, theoretical basis for the
intervention. We view these principles as tools to guide the intervention, with the expectation
that certain principles are foregrounded, or recede into the background, depending on the clinical
“puzzle” the therapist is trying to solve.
The first principle concerns the context in which human behavior occurs. The connection
between person, context, and occupation is embedded in the central tenets of our profession
(American Occupational Therapy Association, 2014), and features prominently in much of the
field’s theoretical work on occupation (e.g., Dickie, Cutchin, & Humphry, 2006; Kielhofner &
Burke, 1980; Strong, Rigby, Stewart, Law, Letts & Cooper, 1999). The REAL intervention also
draws on the social-ecological model of health behavior (McLeroy, Bibeau, Steckler & Glanz,
18
Figure 1.2. Core intervention principles for REAL intervention
1 Mc Leroy, et al. (1988); Strong, et al. (1999)
2 Clark (1993); Frank (2006); Mattingly (1998)
3 Scobbie, Dixon, and Wyke (2011); Wood, Quinn, and Kashy (2002)
4 Resnicow and Page (2008); Wilson, Holt, & Greenhalgh (2001)
1988), which we view as being highly complementary to the philosophy of occupational therapy,
as well as a useful tool for communication and dissemination across disciplinary boundaries.
Taken together, these theories provide a useful structure for understanding the interrelationships
between individuals’ body structures and functions, and their social, cultural, and built
environments, as they influence human occupations.
The second principle concerns the use of narrative in the context of occupational therapy
intervention. Therapists use narrative to develop an understanding of the client’s life history,
including their understanding of how diabetes fits into their overall life story, drawing on
Mattingly’s (1998) work in clinical reasoning and Clark’s (1993) occupational storytelling and
storymaking. Additionally, therapists use narrative as a communication strategy, which has been
Context:
Human occupations are situated
biologically, socially, culturally,
and temporally
1
Narrative:
Occupations take meaning from the
stories we construct about our past
and our future
2
Habits:
Activities can be classified as
either intentional (goal-directed) or
automatic (habitual)
3
Complexity:
Changes in activities are seldom
linear and predictable, and often
have "ripple" or "spillover" effects
4
Core
Intervention
Principles
19
shown to be an efficacious means of persuasion and conveying information in healthcare
contexts (e.g., Lemal & Van den Bulck, 2010; Mishali, Sominsky, & Heymann, 2010).
The third principle concerns the distinction between goal-directed and habitual actions,
and selection of appropriate intervention strategies for each mode of activity. Goal-directed
actions occur when we explicitly aim to perform a given activity. In contrast, habitual actions are
those we perform without conscious thought. Nearly half of our everyday activities are driven by
habit (Wood, Quinn, & Kashy, 2002), and many of these activities are relevant to health. The
REAL intervention draws on the emerging body of habit research to help clients develop and
maintain healthful habits (such as taking medications) and break potentially harmful habits (such
as excess sweetened beverage consumption).
The fourth principle concerns our understanding of individuals as complex systems.
Complexity theory has been identified as particularly relevant to diabetes care, given that blood
glucose control is “a classic example of a complex adaptive system” (Cooper & Geyer, 2009, p.
762). Complexity theory is highly congruent with the principles outlined above concerning
context, narrative, and habits versus goal-directed activities. We therefore view complexity
theory as an overarching principle, providing a coherent framework for the application of the
previously described principles. Complexity theory aims to explain the behaviors of complex
systems, which have emergent properties, such that the whole is greater than the sum of its parts.
Complex systems tend to have overarching behavioral patterns and a capacity for self-
organization, which at the level of an individual person may be seen as analogous to habits and
routines. This provides a framework for understanding an individual’s previous life experiences,
shifting life context, and changes in their behavioral patterns over time, which may, in turn,
20
provide clues regarding potentially effective intervention strategies (Resnicow & Page, 2008;
Wilson, Holt, & Greenhalgh, 2001).
REAL intervention structure and content. The Stage 1 REAL manual was comprised
of seven modular content areas, as outlined in Table 1.1. Module 1 focuses on introducing the
intervention, assessment, and establishing goals. Modules 2-6 each address a specific content
area relevant to diabetes management. Each module contains the following components: (1) a
brief module-specific assessment; (2) suggested treatment goals and activities; (3) activity
handouts and materials; and (4) a therapist reference guide for the module’s content. While the
suggested goals and activities for each module provides a starting point for treatment planning,
therapists have the latitude to implement individualized goals and activities in accordance with
clients’ needs and interests, as long as they are consistent with the focus of the module and the
intervention’s theoretical principles. Module 7 has a fixed format similar to Module 1, in which
clients and therapists reflect on the client’s accomplishments, develop future goals, and identify
community resources for continued diabetes support.
In the REAL feasibility study, the first and last modules were delivered in a standardized
format with each client. Modules 2–6 were implemented flexibly, in accordance with clients’
individualized goals and diabetes care challenges. The module sequence, time spent on each
module, and particular activities completed, could vary according to each client’s needs. The
total contact hours for each module, across all sessions, ranged from 4.8 hours (6.7% of total
treatment time) for Module 3 to 27.8 hours (38.8% of total treatment time) for Module 2, with a
median of 6.0 hours per module. Excluding the fixed modules administered in the first and last
session, the number of sessions in which modules were discussed ranged from 19% (Module 6)
to 78% (Module 2). A review of participants’ individualized treatment plans also illustrates the
21
tailoring of the intervention. For example, Client 1 worked on Modules 2 and 3 for six sessions
each, and Modules 4-6 for one session each; by contrast, Client 2 worked on Module 2 for 10
sessions, Module 5 for 7 sessions, Module 6 for four sessions, and Modules 3 and 4 for one
session each.
Stage 2 Intervention Manual Revisions
Revisions to the REAL intervention manual were guided by findings from a feasibility
study, which aimed to “road test” the Stage 1 intervention manual and determine its strengths
Table 1.1. Overview of intervention manual contents
Module Structure Contents Topics
1. Setting
Goals
Fixed
Fixed goals
Fixed
activities
Assessments
Health history questionnaire
Review of life history & typical day
Readiness to change
Goal setting
2. Living
with
Diabetes
Tailored
Module
competencies
Suggested
goals
Suggested
activities
Client
resources
Therapist
resources
Understanding diabetes
Diabetes treatments and complications
Monitoring
3. Access and
Advocacy
Finding a care provider
Making treatment decisions
Communicating with care providers
4. Activity
and
Health
Daily habits and routines and diabetes
self-care
Risky activities: Drinking, smoking,
family planning
Diabetes dilemmas
5. Social
Support
Family and household life
Diabetes in social situations
Connecting with others who have
diabetes
Intimate relationships & diabetes
6. Emotions
and
Wellbeing
Managing difficult emotions
Stress and diabetes burnout
Positive coping strategies
7. Long-term
Health
Fixed
Fixed goals
Fixed
activities
Reflecting on new knowledge and skills
Identifying resources
Planning for the future
22
and areas for improvement. Additionally, the revisions incorporated elements of a Stage 2
manual, as specified by Carroll and Nuro (2002), which were absent by design from the Stage 1
manual. An overview of the revisions undertaken in advancing from a Stage 1 to a Stage 2
manual are summarized below.
Revisions to REAL intervention structure. Because implementation of the feasibility
study was limited by logistical constraints, the timing and duration of the intervention was
identified by both participants and the therapist as a major limitation. Therefore, it was
determined that the Phase 2 intervention would be implemented over six months, rather than
three months as originally planned. Additionally, due to feedback that the scheduling of sessions
was overly restrictive, the therapist was given latitude to determine individualized treatment
schedules for each participant, while maintaining the total intervention dose within a specific
range of hours. Guidelines for intervention pacing, scheduling sessions, and summarizing
intervention content were also incorporated based on the therapist and participant suggestions.
Additionally, the documentation forms were revised to facilitate easier charting and more
comprehensive tracking of client goals. In the feasibility study, the therapist listed goals on each
treatment note, which made it difficult to accurately and consistently track progress; the revised
forms have a separate sheet for goal documentation and tracking. In addition, to simplify
treatment notes, the most commonly-used activities were converted to checklist form (with an
“other” category to specify less common activities), which allowed for more efficient data entry.
Another significant revision to the REAL intervention structure involved the use of text
messaging. While this had not been specified as part of the Stage 1 protocol, it emerged
spontaneously as a strategy viewed by both the therapist and participants as a useful and efficient
way to reinforce intervention content between sessions. As such, a text messaging protocol was
23
incorporated into the Stage 2 protocol to delineate appropriate uses of text messaging in the
intervention.
Revisions to REAL intervention content. During the feasibility study, the treating
therapist uncovered certain client concerns, such as the safety of getting tattoos, which had not
arisen in the initial needs assessment but which fit within the scope of the intervention modules.
In such cases, additional resources were identified or created to address those needs. The initial
assessments completed in Module 1 were revised significantly in response to the therapist’s
feedback. Certain assessment domains were added while others, which elicited information that
could be obtained from other sources, were eliminated.
A number of suggested content revisions pertained to the therapist training materials. The
feasibility study therapist identified a need to better understand “typical” diabetes care strategies
among the target population. Therefore, four in-depth case studies, and several shorter vignettes,
were incorporated into the therapist training. These case studies and vignettes were based on the
actual diabetes care practices and life circumstances of needs assessment and feasibility study
participants. Also, a bibliography of additional resources and readings were included in the
therapist’s reference guide to address more obscure diabetes care issues that may arise with
clients.
Incorporation of Stage 2 manual elements. In advancing from a Stage 1 to a Stage 2
manual, Carroll and Nuro (2002) suggest that additional intervention parameters be specified
regarding therapist selection, training, and supervision; differences between the intervention and
other treatments; and processes to evaluate intervention fidelity. Several revisions to the
[redacted] intervention manual were undertaken to achieve these goals. First, while we had
already specified therapist selection and training standards, we provided additional details
24
regarding training objectives and recognized continuing education providers. Second, to address
fidelity monitoring, therapist documentation forms were revised to include reporting on key
aspects of the intervention, and a fidelity checklist was developed to facilitate evaluation of
therapy sessions. Finally, we clarified key differences and similarities with other interventions,
including other diabetes education programs and occupational therapy interventions using the
Lifestyle Redesign approach. With respect to diabetes education programs, a key similarity is our
focus on diabetes self-management behaviors as targets of the intervention. A key difference is
our emphasis on integrating these behaviors into everyday occupations and routines, rather than
teaching self-management knowledge and skills. With respect to other Lifestyle Redesign
interventions, this intervention is similar in its emphasis on everyday habits and routines, but
differs in its delivery mechanism and tailoring of content to a particular developmental stage.
Conclusion
The purpose of this paper was to illustrate the process of development, feasibility testing,
and revision of an occupational therapy intervention manual. While we drew upon our research
team’s experiences developing an intervention targeting diabetes management, this process could
be applied to any clinical problem in occupational therapy practice.
Intervention development is inherently an iterative process which draws on one’s
experiential knowledge and clinical reasoning; the needs and concerns of a particular population;
and information from the research literature. Viewing a clinical problem through each of these
lenses provides insight regarding a theoretical framework from which to approach the problem,
and practical considerations for intervention delivery and dissemination, both of which must be
revisited at each stage of manual development. For example, from a theoretical standpoint,
clinic-based group meetings may have been an ideal strategy for implementing our intervention,
25
because of the opportunity for group problem-solving and social support. However, the target
population’s low clinic attendance and low uptake of a previous clinic-based group intervention
(Weigensberg et al.) guided our decision to provide the intervention in participants’ homes, to
ensure delivery of an adequate treatment dose to accurately assess the intervention’s effect.
Although this strategy is appropriate for efficacy research (in which an ideal form of an
intervention is tested under tightly controlled conditions), these considerations must be revisited
if the intervention is to be translated into broad application. For example, our pilot test of a text
messaging component in the Stage 2 manual may pave the way toward a future mobile health
implementation of the intervention. This is just one illustration of how theoretical and practical
tradeoffs are navigated, and how these factors may be weighed differently depending on the
stage of intervention development.
Limitations
While this study reports on the development and manualization of an evidence-based
intervention, research evaluating the efficacy of this intervention is still underway. Therefore,
some of the intervention strategies outlined in this paper may need to be revisited if the
intervention is shown not to be efficacious. Furthermore, as previously discussed, the
intervention in its current form is relatively resource intensive, and would not be feasible to
deliver in most practice settings. If the intervention demonstrates efficacy, further development
will be necessary to translate the intervention principles and strategies into a Stage 3 intervention
manual that is practical and cost-effective to deliver on a broader scale.
In summary, intervention manuals are a critical tool for developing the evidence base for
occupational therapy clinical practice. Developing intervention manuals is an iterative process,
with their form and purpose differing depending on the stage of the research-to-clinical practice
26
pipeline. Developing a flexible intervention framework allows for manuals to navigate the
competing demands of defining core intervention elements and allowing for clinical judgment.
27
Chapter 2: K01 Grant Application Specific Aims and Research Strategy
Specific Aims
Type 1 diabetes mellitus (T1D) is the second-most common serious childhood disease in
the United States (Borus & Laffel, 2010) and its incidence is increasing at an annual rate of 3.8%
(Patterson et al., 2009). Meanwhile, type 2 diabetes (T2D) has been identified as an “emerging
epidemic” in youth, paralleling the rise in childhood obesity (Kaufman, 2002; Rosenbloom, Joe,
Young, & Winter, 1999). Recent data from the SEARCH study showed that the prevalence of
T2D in youth increased 21% from 2001 to 2009 alone (Dabelea, et al., 2012). Hispanic/Latino
and African American adolescents are at particularly high risk for T2D, which now accounts for
over half of new diabetes diagnoses among 15-19 year olds in these groups (Lawrence et al.,
2009; Mayer-Davis et al., 2009).
The transition to adulthood is particularly challenging for youth with diabetes, as
treatment adherence is low and few attain optimal levels of glycemic control (Reinehr, Schober,
Roth, Wiegand, & Holl, 2008; Rothman et al., 2008). Young adults (YAs) with T1D have
mortality rates 3-6 times higher than those without diabetes (Weissberg-Benchell, Wolpert, &
Anderson, 2007), and are at elevated risk for mental illness, substance abuse, and diabetic
complications (Bryden, Dunger, Mayou, Peveler, & Neil, 2003; Bryden et al., 2001; Northam,
Lin, Finch, Werther, & Cameron, 2010). YAs with T2D have more rapid onset of complications
than other populations with T1D or T2D, and high rates of cardiovascular risk factors (Eppens et
al., 2006; Karabouta, Barnett, Shield, Ryan, & Crowne, 2008). Diabetes health disparities persist,
as African-American and Hispanic/Latino adults have a higher prevalence of diabetes, and
higher rates of diabetes-related complications, hospitalizations, and mortality, compared to non-
Hispanic Whites (Peek, Cargill, & Huang, 2007; U.S. Department of Health and Human Services
28
Office of Minority Health, 2014). Despite the urgency of these clinical problems, diabetes self-
management interventions have had limited success in producing lasting improvements in health
outcomes (Gary, Genkinger, Guallar, Peyrot, & Brancati, 2003; Norris, Lau, Smith, Schmid, &
Engelgau, 2002). Additionally, there are no interventions tailored to meet the needs of minority
YAs with diabetes, a particularly high-risk group.
In response to these challenges, the proposed mentored research project aims to pilot-test
an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting
underserved minority YAs with poorly-controlled diabetes (A1C ≥8.0%). The individually
tailored, community-based intervention, developed during my KL2 award, merges findings of an
in-depth needs assessment, principles of an evidence-based occupational therapy intervention
(Lifestyle Redesign) (Blanche, Fogelberg, Diaz, Carlson, & Clark, 2011; Clark et al., 1997; Clark
et al., 2012; McNulty, 2012), and evidence-based diabetes self-management strategies (Hill-
Briggs et al., 2011; King et al., 2010; Rosal et al., 2011; Sarkar, Fisher, & Schillinger, 2006). A
proof-of-concept study (n = 8) demonstrated that REAL is feasible to implement, acceptable to
YAs with type 1 and type 2 diabetes, and has potential to produce positive changes in diabetes
self-care and glycemic control. Refinements to the intervention, such as inclusion of a mobile
health component, were made in response to focus group feedback from participants.
The proposed study will randomize 80 YAs with poorly-controlled diabetes to receive
either the 6-month REAL intervention or an attention control condition matched for intervention
dose. Blinded testers will assess primary and secondary outcomes, as well as potential
intervention mediators, before and after the 6-month intervention period. Additionally, a rigorous
process evaluation will be executed to evaluate intervention implementation and study
29
procedures. It is anticipated that findings from this pilot study will be used to inform a large-
scale RCT of the intervention, supported through an R01 or similar funding mechanism.
The K01 proposal represents a natural extension of my KL2 project (developing and
testing the feasibility of the REAL intervention) by evaluating its efficacy in improving A1C and
diabetes self-care. The training and mentoring inherent in the K01 award will allow me to
develop skills in conducting RCTs and implementing cutting-edge health behavior interventions
among a high-risk population. My primary goal is to develop the skillset necessary to execute
large-scale RCTs of complex interventions addressing the health needs of underserved and
minority populations with diabetes. The specific aims of the project are as follows:
Aim 1. Determine the intervention’s efficacy for the primary outcomes: glycemic control and
diabetes self-care.
Hypothesis: At 6 months (immediately following the intervention), intervention group
participants will demonstrate improvements in A1C and diabetes self-care as compared to
control group participants.
Aim 2. Conduct exploratory analyses of the intervention’s impact on secondary outcomes and
potential mediating mechanisms (to inform power estimates for a large-scale RCT).
Hypothesis 1: At 6 months (immediately following the intervention), intervention group
participants will demonstrate improvements in secondary outcomes: diabetes-related
stress, diabetes-related quality of life, depression, and life satisfaction as compared to
control group participants.
Hypothesis 2: At 6 months (immediately following the intervention), intervention group
participants will demonstrate improvements in potential mediators of the intervention:
30
habit strength, problem solving, activity participation, self-efficacy and diabetes
knowledge as compared to control group participants.
Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention
delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment,
retention, testing protocol).
Significance:
Diabetes care: The long-term health benefits of tight glycemic control (A1C ≤7%) among
patients with type 1 diabetes (T1D) have been definitively demonstrated (Diabetes Control and
Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC)
Research Group, 2005; The Diabetes Control and Complications Trial Research Group, 1993).
Although studies have shown more ambiguous results regarding intensive control for type 2
diabetes (T2D) (Currie et al., 2010; Holman, Paul, Bethel, Matthews, & Neil, 2008; Turnbull et
al., 2009), overall the evidence demonstrates a benefit in preventing microvascular complications
and myocardial infarction (Gaede, Lund-Andersen, Parving, & Pedersen, 2008; Hemmingsen et
al., 2011; Ray et al., 2009; Zoungas et al., 2009). Furthermore, while intensive control may not
be an attainable goal for all, there is widespread consensus that an A1C <8% is desirable for
virtually all adults with diabetes, and an A1C ≥9% constitutes an unacceptable health risk (Ali et
al., 2012; American Diabetes Association, 2012; Gerstein et al., 2007).
Maintaining glycemic control is particularly difficult in young adulthood, when
competing priorities and developmental challenges create barriers to diabetes self-care (Garvey
& Wolpert, 2011; Hessler, Fisher, Mullan, Glasgow, & Masharani, 2011; Hessler, Fisher,
Naranjo, & Masharani, 2011; Peters & Laffel, 2011). Typical A1C values for young adults
(YAs) with T1D are 8-9% (Lane et al., 2007; Sparud-Lundin, Ohrn, Danielson, & Forsander,
31
2008), and close to 10% among YAs receiving care at the study’s proposed recruitment sites
(Pyatak et al., 2013; Sequeira et al., 2013). YAs with T1D have high rates of diabetes
complications (25% of men, 38% of women) (Bryden et al., 2001), psychiatric morbidity
(Northam et al., 2010), and a 3-6-fold increase in mortality compared to nondiabetic peers
(Weissberg-Benchell et al., 2007). Although YAs with T2D have better glycemic control overall
(Copeland et al., 2011; Lawrence et al., 2009; Mayer-Davis et al., 2009), they appear to be at
elevated risk for complications. Preliminary research suggests an aggressive disease course, with
more rapid onset of microvascular complications compared to both their peers with T1D (Eppens
et al., 2006) and older populations with T2D (Karabouta et al., 2008).
Because most diabetes care is performed by the individual in the context of everyday life,
adherence to self-care recommendations is vital to maintaining glycemic control. However,
meta-analyses of clinical trials evaluating diabetes self-management interventions have shown
muted effects on glycemic control, ranging from no effect to a 0.43% between-group difference
in A1C (Gary et al., 2003; Hood, Rohan, Peterson, & Drotar, 2010; Minet, Møller, Vach,
Wagner, & Henriksen, 2010; Winkley, Ismail, Landau, & Eisler, 2006). Additionally, positive
effects tend to decay rapidly after intervention completion (Norris et al., 2002). Translating
knowledge gained from seminal studies such as the UKPDS and DCCT into improved
population health, therefore, requires innovative intervention strategies, particularly among
populations at high risk for low adherence to diabetes self-care, and poor health outcomes
(Reinehr et al., 2008; Rothman et al., 2008; U.S. Department of Health and Human Services
Office of Minority Health, 2014).
Diabetes among underserved young adults. There are few empirical studies of lifestyle
interventions to improve diabetes care in YAs, despite a growing body of research identifying
32
their unique barriers to self-care (Garvey & Wolpert, 2011; Hessler et al., 2011; Hislop, Fegan,
Schlaeppi, Duck, & Yeap, 2008; Peters & Laffel, 2011; Wolpert, Anderson, & Weissberg-
Benchell, 2009). Studies evaluating such interventions are generally specific to T1D; a recent
review concluded that these interventions are successful in reducing loss to follow-up, but not in
improving glycemic control or psychosocial outcomes (Daneman & Nakhla, 2011). In addition,
none of the identified interventions targeted uninsured, low-SES, or minority populations. YAs
with T2D have, to date, not generally been considered as a distinct population, although they
have greater chronic stress and negative life events, higher A1C, and higher diabetes-related
stress than older adults with T2D (Hessler et al., 2011). A notable exception, the TODAY trial,
examined the efficacy of a family-based weight loss intervention in combination with metformin
among ethnically diverse youth aged 10-17 with T2D; results showed that the weight loss
intervention was not significantly different than metformin alone in maintaining glycemic
control (The TODAY Study Group, 2012). Given existing interventions’ modest or null effects,
and the complex barriers to diabetes care encountered by underserved minority YAs, we posit
that a more intensive, multifaceted intervention may be warranted to improve health in this
population.
Healthcare costs associated with diabetes. Overall, people with diabetes have medical
costs approximately 2.3 times higher than those without diabetes (American Diabetes
Association, 2008). Moreover, these costs accelerate over time. Each additional year an
individual has diabetes increases their annual medical costs by $158, approximately half of
which is attributable to diabetes complications (Trogdon & Hylands, 2008). Young people with
poorly controlled diabetes, who will have diabetes for many years and are vulnerable to
complications due to poor glycemic control, are therefore likely to incur substantial medical
33
expenses over their lifetimes. As such, improving diabetes care in this population is potentially a
fruitful strategy for lowering overall healthcare costs associated with diabetes. Accordingly,
previous research has noted that targeting poorly controlled diabetes provides the greatest return
on investment for diabetes interventions in youth (Gage et al., 2004).
The Lifestyle Redesign approach: In diabetes, as with many chronic conditions, much of
the potential to improve health stems from the individual’s ability to enfold self-care strategies
within their existing daily activities, and adapt these strategies as life circumstances change over
time. Individuals who succeed in changing health behaviors often relapse when contextual
circumstances shift (Wood, Tam, & Witt, 2005), and YAs, whose lives are often less stable than
other age groups, frequently experience such contextual shifts (Arnett, 2004). The REAL
intervention aims to equip YAs with tools to evaluate such life changes and implement strategies
to maintain diabetes self-care over time. The REAL intervention was developed in accordance
with the principles of Lifestyle Redesign, a preventive occupational therapy intervention
approach shown to cost-effectively slow health declines and improve well-being among
ethnically diverse, low income community-dwelling older adults (Clark et al., 1997; Clark et al.,
2012), and to sustain these benefits over the long term (Clark et al., 2001). Lifestyle Redesign
has been translated into interventions addressing conditions such as chronic headaches, pressure
ulcer prevention, and weight management, among ethnically diverse populations ranging from
college students to elders (Blanche et al., 2011; McNulty, 2012; Vaishampayan, Clark, Carlson,
& Blanche, 2011). While data on the efficacy of these adaptations is pending, the approach has
proven to be feasible and acceptable for a variety of populations.
34
Innovation:
The REAL intervention is informed by complexity science, which seeks to explain the
actions of complex adaptive systems inadequately described in traditional reductionist models
(Kernick & Sweeney, 2001; Plsek & Greenhalgh, 2001; Resnicow & Page, 2008). This approach
conceptualizes lifestyle as an emergent entity, influenced by multiple interacting agents ranging
from the cellular to the societal. In the domain of health behavior, complexity science is closely
related to participatory and social-ecological models of health (Van Beurden, Kia, Zask,
Dietrich, & Rose, 2013), and posits that small, seemingly insignificant changes in one domain of
behavior may alter a person’s patterns of living in ways that have unpredictable “ripple” effects
in other domains.
Guidelines have been developed for implementing health interventions for complex
adaptive systems (Wilson, Holt, & Greenhalgh, 2001), and the REAL intervention and Lifestyle
Redesign approach are grounded in three overarching principles consistent with these guidelines
(Jackson, Carlson, Mandel, Zemke, & Clark, 1998): (1) holism, or consideration of the person in
context as a complex adaptive system; (2) attention to habit and routine, as overarching
behavioral patterns which tend to repeat over time; and (3) emphasis on narrative and life
history, which reveal how diabetes has related to one’s life goals and experiences over time,
providing insights regarding potentially effective intervention strategies. In addressing diabetes
care from a complexity science perspective, the REAL intervention has sufficient flexibility to
address a range of relevant health behaviors in a context in which risk behaviors are often high,
disease management may be a low priority, and social context plays a prominent role in health
decision making.
35
Approach:
I propose to carry out a pilot randomized controlled trial (RCT) involving young adults
with poorly-controlled diabetes (A1C ≥8.0%) recruited from LA County diabetes clinics and
emergency departments. Fifty-six participants will be randomized to receive either the 6-month
REAL intervention, or an attention control matched for number of intervention visits. We
hypothesize that the intervention will influence diabetes self-care and, in turn, glycemic control,
by increasing participants’ habit strength, problem solving, activity participation, diabetes
knowledge, and self-efficacy, as illustrated in Figure 1. Data will be collected at baseline and 6
months (post-intervention), and will include assessment of general demographics, primary
outcomes (A1C and diabetes self-care), secondary outcomes (diabetes-related stress and quality
of life, depression, and life satisfaction), and hypothesized mediators. The study will be
completed over a 3-year period including start-up and recruitment, intervention delivery, data
analysis, and dissemination of findings. Conducting the study as a career development award
will allow for training and mentorship in RCT implementation and process evaluation so that,
upon study completion, I will be equipped with the skills needed to implement large-scale RCTs
of complex behavioral interventions. In addition, this project will allow me to collect pilot data
needed to support a large-scale study to rigorously evaluate the efficacy, underlying mediators
and effect modifiers, and long-term effects of the intervention.
Aims and Hypotheses:
Aim 1. Determine the intervention’s efficacy for the primary outcomes: glycemic control and
diabetes self-care.
36
Hypothesis: At 6 months (immediately following the intervention), intervention group
participants will demonstrate improvements in A1C and diabetes self-care as compared to
control group participants.
Aim 2. Conduct exploratory analyses of the intervention’s impact on secondary outcomes and
potential mediating mechanisms (to inform power estimates for a large-scale RCT).
Hypothesis 1: At 6 months (immediately following the intervention), intervention group
participants will demonstrate improvements in secondary outcomes: diabetes-related stress
and quality of life, depression, and life satisfaction as compared to control group
participants.
Hypothesis 2: At 6 months (immediately following the intervention), intervention group
participants will demonstrate improvements in potential mediators of the intervention: habit
strength, problem solving, activity participation, self-efficacy and diabetes knowledge as
compared to baseline.
Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention
delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment,
retention, testing protocol).
Preliminary Studies:
Through my KL2 award, I conducted research to address the following aims: (1) conduct
an in-depth needs assessment among urban minority young adults with T1D or T2D, (2) develop
a lifestyle intervention manual for the target population, and (3) complete a small-scale proof-of-
concept study (n = 8) of the intervention.
Phase 1 was comprised of two related qualitative studies on barriers to diabetes care
among minority YAs recruited from the LA County public healthcare system. In Study 1, 20
37
YAs with T1D were interviewed upon enrollment in a young adult diabetes clinic. In Study 2, 8
purposively sampled YAs with T2D each completed 4-8 semi-structured interviews. Interviews
were conducted in participants’ homes, audiotaped, and transcribed for thematic analysis
(Riessman, 2008). These studies revealed significant barriers to diabetes care in the target
population. Participants had a high prevalence (75-80%) (Pyatak, Sequeira, Whittemore, Vigen,
Peters, & Weigensberg, 2014) of psychosocial stressors (median: 2.5), which were significantly
associated with A1C (0.60, p = 0.005) (Pyatak, Sequeira, Peters, Montoya, & Weigensberg,
2013). These studies also highlighted similarities and differences in barriers to diabetes care for
YAs with T1D versus T2D. For instance, YAs with T2D were more likely than those with T1D
to live with family members who also had diabetes; these family members’ approach to diabetes
care often influenced the YAs’ views on appropriate care strategies. While there were differences
in some aspects of diabetes care, they shared many challenges, including poor access to care,
limited self-advocacy skills, a lack of established self-care routines, a high prevalence of
psychosocial stressors, and limited coping skills for managing stress. The REAL intervention
addresses these issues, and in the proof-of-concept study, was able to be flexibly applied through
individual tailoring to adapt to the differing needs of YAs with T1D versus T2D.
Phase 2 of the KL2 award entailed developing an intervention manual to address the
identified needs of the target population. The manual contents were derived from extant
information on effective diabetes self-care strategies; principles of Lifestyle Redesign; and
information gleaned from the needs assessment regarding diabetes care challenges of the target
population. An initial manual was developed and reviewed by a panel of experts including
endocrinologists, dieticians, CDEs, health behavior researchers, and occupational therapists
38
trained in Lifestyle Redesign; feedback from this panel was then incorporated into a revised
manual.
Phase 3 of the KL2 award entailed delivering an abbreviated version of the intervention
to 8 young adults (6 with T1D, 2 with T2D) as a proof-of-concept study. One participant was lost
to follow-up after one intervention session; the remainder completed a median of 8 weekly
sessions (range: 6-12) over a 2-month period. We completed an assessment protocol including
chart review, A1C testing, and survey administration at baseline and post-intervention.
Additionally, after completing all assessments, participants were invited to a focus group to
provide feedback on the acceptability of the intervention. Although the study was not powered to
detect significant pre-post differences, we were encouraged by positive changes in several
targeted domains as outlined in Table 2.1.
Qualitative feedback from the intervener and participants indicated that the intervention
was highly relevant to participants’ diabetes care needs. However, it was felt that intervention
Table 2.1. Proof-of-Concept Study Outcomes (n=7 with complete data)
A1C (%)
Checks
blood
glucose as
directed
Takes
insulin/
medication
as directed
Depression
(PHQ-9)
Diabetes-
related stress
(PAID)
Life
satisfaction
(SWLS)
Scale
range
--
0-7
days/week
0-7
days/week
0-27 0-80 0-35
Baseline
10.9 (±
1.5)
3.6 (± 3.1) 4.8 (± 3.3) 5.4 (± 6.6) 18.6 (± 13.4) 23.7 (± 6.7)
Post-test
10.8 (±
1.3)
4.0 (± 3.0) 5.0 (± 2.7) 2.4 (± 1.9) 14.9 (± 5.7) 25.7 (± 4.0)
Effect
size*
0.14 0.52 0.20 0.80 0.28 0.80
*Cohen’s d for within-subject studies (correcting for dependence among means)
39
visits should be more flexible (longer or shorter depending on participants’ needs), and that text
message reminders or “boosters” would be a useful strategy to augment in-person sessions.
Additionally, the occupational therapist provided feedback on which intervention strategies were
most successful, and recommended supplemental materials for inclusion in the intervention
modules. This feedback was incorporated into a revised intervention protocol to be used in the
proposed study.
Participants:
Study entry criteria are outlined in Table 2.2. Criteria were chosen to ensure a medically
stable pool of participants (≥12 months post-diagnosis, not pregnant) and minimize bias from
participation in related studies. In addition, the relatively intensive intervention is most
appropriate for those with demonstrated diabetes care challenges, as evidenced by poor glycemic
control. Fifty-six participants will be recruited from LAC+USC outpatient diabetes clinics and
emergency department, Children’s Hospital Los Angeles, and the Roybal Community Health
Table 2.2. Study Entry Criteria
Inclusion Criteria Exclusion Criteria
Diagnosis of T1D or T2D for ≥12 months
Pregnant or planning to become pregnant
within the next 6 months
A1C ≥8.0% at last clinic visit or per point-of-
care assay at study enrollment
Participant in a diabetes-related lifestyle
intervention within the past 12 months
Age 18-30 yrs. at time of study enrollment
Resident of Los Angeles County with no plans
to relocate within 12 months
Participant in research related to
intervention development
40
Center diabetes management program. These sites collectively serve over 500 patients with
diabetes who meet inclusion and exclusion criteria for the current study.
Two strategies will be utilized to enroll study participants. At higher-volume recruitment
sites (serving ≥3 patients per day meeting study entry criteria), a research assistant will identify
and approach prospective participants on-site during clinic visits. At lower-volume sites,
participants will be identified either through medical record review, or by collaborating
healthcare providers forwarding, with patients’ permission, prospective participants’ contact
information to study personnel for follow-up. Inclusion of Children: We will include children
age 18-20 in the study. Given that the intervention specifically targets the developmental
challenges of this age group, we believe this to be a necessary and appropriate age limitation.
Procedures:
Research activities are summarized in Table 2.3 on the following page. During a 3-
month start-up period, we will finalize a Manual of Procedures, hire and train study personnel,
develop a database for participant tracking and secure data storage, finalize fidelity measures,
develop a protocol for implementing a text messaging component of the intervention, and
assemble a Data and Safety Monitoring Committee (DSMC). We anticipate that recruitment will
begin at 4 months and be completed by 16 months, entailing a conservative enrollment rate of 5
participants per month. Following study enrollment, participants will complete in-home
assessments administered by a trained research assistant, and then be randomly assigned to the
intervention or control condition.
Intervention delivery will take place during months 5-22, with participants completing
follow-up assessments in months 11-28. Additionally, focus groups will be convened among
intervention recipients (in three waves, following their completion of follow-up assessments) to
41
Table 2.3. Timeline of Planned Research Activities
Research Task Month of Study
3 6 9 12 15 18 21 24 27 30 33 36
Research team meetings (weekly)
Mentoring team meetings (monthly)
Start-up/Recruitment
Hire/train study personnel
Complete database & MOP
Convene DSMC
Recruit participants
Administer baseline testing
Intervention delivery
Conduct intervention visits
Administer follow-up testing
Conduct focus groups
Data analysis & Dissemination
Data entry, data cleaning
Primary & secondary analyses
Manuscript preparation
Grant proposal preparation
42
obtain participants’ subjective impressions of the intervention’s efficacy, mechanisms of action,
and carryover after completing the intervention.
Data entry and data cleaning will be carried out on an ongoing basis during baseline and
follow-up assessment administration. Data analyses will begin in month 30, after all follow-up
data have been collected, entered, and cleaned. Dissemination of research findings will be
ongoing as analyses are completed. Preparation of an R01 grant proposal will be a primary focus
during the final year of the K01 award.
Intervention Approach:
The REAL intervention is a manualized, individually tailored intervention, which is both
data-based and theoretically grounded. It was derived from findings of the needs assessment
previously described, as well as complexity theories (Kernick & Sweeney, 2001; Plsek &
Greenhalgh, 2001; Resnicow & Page, 2008), habit change theories (Neal, Wood, Labrecque, &
Lally, 2012; Orbell & Verplanken, 2010; Verplanken & Wood, 2006), patient empowerment
(Anderson & Funnell, 2005), and the transtheoretical model of change (Norcross, Krebs, &
Prochaska, 2011), and therapeutic strategies drawn from Lifestyle Redesign (Clark et al., 1997;
Clark et al., 2012) and motivational interviewing (Rollnick, Miller, & Butler, 2008).
Intervention adaptation. The REAL intervention retains the principles and philosophy of
Lifestyle Redesign, which include a holistic view of health, emphasis on optimizing daily habits
and routines, and utilization of narrative and life history to inform intervention goals and
strategies (Jackson et al., 1998). The topical content and delivery methods, however, have been
modified to the target population’s developmental stage, diagnosis, and logistical preferences.
For example, there is an emphasis on use of web-based social networking as a means of social
support, and family planning, alcohol use, and illicit drug use are addressed.
43
Cultural adaptations were also embedded in the process of intervention adaptation. For
example, in contrast to much of the literature on emerging adults (Luyckx & Seiffge-Krenke,
2009; Weissberg-Benchell et al., 2007), in our needs assessment we found that YAs in our
setting typically do not move out of the family home, for both cultural and economic reasons. As
such, we incorporated strategies in the REAL intervention for healthy eating when the YA is not
the primary decision maker regarding household food purchases. More broadly, the principles of
Lifestyle Redesign, including a holistic consideration of the person in context and an emphasis
on understanding an individual’s life history, allow for the REAL intervention to be implemented
flexibly and in accord with participants’ cultural beliefs.
Language and cultural congruence will be primary considerations in hiring therapists to
deliver the REAL intervention. Although the majority of our target population speaks English as
a first or second language, we will employ a bilingual therapist to accommodate participants who
prefer Spanish and to facilitate communication with Spanish-speaking household members. The
portions of the intervention manual which are used by participants are currently being translated
by a bilingual research assistant who previously translated another Lifestyle Redesign
intervention delivered in English and Spanish (Blanche et al., 2011).
Intervention implementation. The REAL intervention will be delivered in 12
approximately biweekly sessions over a 6-month period, in participants’ homes or other sites in
their local communities. In keeping with feedback from the proof-of-concept study, some
flexibility regarding the timing and duration of sessions will be allowed, at the therapist’s
discretion. However, in-person contact hours will be tracked on an ongoing basis, and capped at
16 hours per participant. In addition, text messaging will be implemented to augment in-person
contact; the protocol for this aspect of the intervention will be developed with input from Dr.
44
Spruijt-Metz during the start-up phase of the study. The number and content of text messages
will also be tracked during the course of the study. Participants who do not have a cell phone
with text messaging capability will be provided with a prepaid phone for the duration of the
intervention.
To approximate real-world conditions in which therapists typically have the ability to
discuss cases (formally in rounds, or informally) with other health professionals, an
endocrinologist and a social worker will be retained to provide as-needed consultation to the
intervener. These consultations will support the intervener in triaging medical or mental health
needs which may fall outside the scope of the intervention, enabling the intervener to, in turn,
provide appropriate recommendations to the participant. For example, during the proof-of-
concept study, the social worker was consulted regarding community mental health resources for
a participant who expressed thoughts of self-harm, and the endocrinologist was consulted
regarding the implications of a participant’s disclosure of nonadherence to a blood pressure
medication.
Intervener qualifications. The intervention will be provided by a licensed occupational
therapist (OTR/L) with 20 hours of training in the REAL intervention manual and 12 hours of
training in motivational interviewing. In addition, the OTR/L will have a minimum of 20
continuing education hours in diabetes education within a year of initiating the intervention. This
requirement, more stringent than that for certification as a Certified Diabetes Educator
®
, is
designed to ensure the intervener has sufficient expertise in diabetes care.
Intervention manual. The REAL intervention manual includes resources to address a
range of treatment goals, generated collaboratively using a patient-centered approach. It is
divided into an introductory section describing the intervention protocol and theoretical
45
framework, and an intervention section comprised of seven modules (see Table 2.4). Each
module includes suggested goals, activities to support those goals, patient resources (lay
language materials), and therapist resources (professional education materials). The intervention
is individually tailored, insofar as only modules 1 (assessment) and 7 (long-term planning and
discharge) are utilized with all participants; the remaining modules are selected according to
participants’ individual goals. It is designed to be flexible, allowing therapists to respond to
emergent issues (e.g., job loss, family crisis) which threaten the patient’s diabetes self-care and
overall health.
The manual exists as both a hard copy and digitally on a web-enabled tablet to facilitate
real-time access to internet resources. For example, if a participant’s goal is to develop a plan to
get to a medical appointment, they may access a transit website to view bus schedules during an
intervention session. The manual emphasizes activity-based intervention strategies such as role-
playing, environmental modification, or direct engagement in activity (such as eating a meal with
a participant aiming to improve his/her carbohydrate counting skills, or exploring diabetes-
related social media sites with a participant aiming to develop a support network of people with
diabetes).
The REAL intervention is designed to address self-care recommendations for both T1D
and T2D. Intervention goals and strategies are tailored to each participant’s particular treatment
regimen, self-care recommendations, and lifestyle-related barriers to adherence. As such,
the intervention is sufficiently flexible to accommodate variability between T1D and T2D care,
such as a greater emphasis on weight management in T2D, or self-monitoring of blood glucose
in T1D. Further, because the intervention is targeted to individuals with poor glycemic control,
participants with T2D are likely to have more complex care challenges than may be typical. For
46
example, both participants with T2D in the proof-of-concept study had no routine diabetes care
provider, had discontinued their diabetes medications against medical advice, and had A1C
values exceeding 9%.
Attention control condition. Participants randomized to the control condition will receive
12 home visits from a bilingual graduate student worker blind to the study design and
intervention approach. At these visits, each participant will be given a pre-specified packet of
Table 2.4. Overview of REAL Intervention Content
Module Topics
1. Assessment
and Goal-Setting
Health history review; life history narrative
Exploration of barriers and supports to diabetes care
2. Living with
Diabetes
What is diabetes? How is it treated?
Understanding acute and long-term complications
3. Access and
Advocacy
Getting care: Finding a care provider, using healthcare benefits
Making treatment decisions, communicating with care providers
4. Activity and
Health
Daily routines and diabetes self-care: making and breaking habits
Risky activities (e.g. drinking, drug use) and diabetes dilemmas
5. Social
Support
Managing diabetes in social situations, dealing with “diabetes police”
Family-household life, peer relationships, and intimate relationships
6. Emotions and
Wellbeing
Emotions and diabetes: anxiety, depression, anger, guilt, denial, fear
Coping with diabetes burnout and self-destructive behaviors
Promoting well-being and developing positive coping strategies
7. Long Term
Health
Planning for the future: Anticipating changes in lifestyle and routine
Adapting to change: Diabetes progression, change in health status
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patient education materials produced by the American Diabetes Association, CDC, or NIH,
which the student worker will review with the participant. We hypothesize that these home visits
will control for the effect of research participation, and that simply providing educational
materials as an intervention modality will have negligible effects on participants’ self-care
behavior (McCarney, Warner, Iliffe, van Haselen, Griffin, & Fisher, 2007).
Data Collection:
Demographic variables to be assessed via self-report include age, gender, race, ethnicity,
and highest level of education completed. Demographic variables to be assessed via chart review
include diagnosis (T1D or T2D), duration of diabetes, current treatment regimen, and incidence
of complications and comorbid conditions. Primary and secondary outcomes and hypothesized
mediators are assessed using the instruments in Table 2.5. A1C is tested using a CLIA-waived
point-of-care device (Axis-Shield Afinion) which collects capillary blood using a standard
finger-prick procedure. All instruments have been validated for use among young adults, and all
except the POPS are available in English and Spanish. The POPS will be translated by a
bilingual Spanish speaker, and back-translated into English, during the study start-up period.
Hypothesized mediators were selected on the basis of (1) being identified as mediators in
previous Lifestyle Redesign interventions (activity participation; F. Clark, unpublished data); (2)
being a focus of the present intervention and having been shown to mediate other health behavior
interventions (habit strength (Gardner, de Bruijn, & Lally, 2011)), or (3) being mediators of
effective diabetes self-management interventions (problem solving (Hill-Briggs et al., 2011;
King et al., 2010), diabetes knowledge (Rosal et al., 2011), and diabetes self-efficacy (Rosal et
al, 2011.; Sarkar, Fisher, & Schillinger, 2006.)).
48
The measures detailed in Table 2.5, along with a demographic questionnaire, will be
administered by a graduate student research assistant blind to condition assignment during in–
home testing sessions at baseline and 6 months. These assessments require approximately 45-75
minutes to complete, and participants will receive a $25 gift card for completing the testing
session. These procedures were piloted in the proof-of-concept study and found to be acceptable
to participants. Materials will be returned to the study office on the same business day for secure
storage of participant data and disposal of medical waste.
In addition to data related to intervention outcomes, data on process variables will be
collected to evaluate and refine the intervention and study procedures. We will collect data on
scheduling and attendance of assessment and intervention sessions, the dose and content of text
messages delivered during the intervention, challenges to study implementation, and any changes
made to the study protocol. To assess intervention fidelity, therapists will complete a brief form
after each session documenting session length, modules addressed, and any deviations from the
study protocol. In addition, a second therapist trained in the intervention protocol will observe
approximately 10% of treatment sessions and complete a checklist assessing fidelity to the
structure and process of the intervention. Following study completion, interveners and research
staff will be interviewed to obtain their views on the intervention and study procedures.
Intervention participants will be invited to attend focus groups (after completing follow-up
assessments) to provide subjective feedback on the impact of the intervention and its
mechanisms of action.
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Table 2.5. Measures of Primary and Secondary Outcomes, and Potential Mediators
Variable Instrument Description
1° Outcome
A1C
Axis-Shield Afinion
point-of-care assay
Meets NGSP certification criteria; correlation
with laboratory A1C measure = 0.991
(Lenters-Westra & Slingerland, 2010; Sanchez-
Mora et al., 2011).
Diabetes self-
care
Summary of
Diabetes Self-Care
Activities (SDSCA)
– adapted
14 items; assesses diabetes self-care behaviors
(Toobert, Hampson, & Glasgow, 2000).
Supplemental questions will assess habit
strength for blood glucose testing and taking
insulin/ medications (Danner, Aarts, & de
Vries, 2008; Gardner, Abraham, Lally, & de
Bruijn, 2012).
2° Outcome
Diabetes
quality of life
Audit of Diabetes-
Dependent Quality
of Life (ADD-QoL)
19 items; assesses social, physical, and
emotional functioning; Cronbach’s α = 0.84 (El
Achhab, Nejjari, Chikri, & Lyoussi, 2008).
Diabetes
stress
Problem Areas in
Diabetes (PAID)
Scale
20 items; measures diabetes-related distress
and emotional problems; Cronbach’s α = 0.93-
0.95 (Garratt, Schmidt, & Fitzpatrick, 2002).
Depression
Patient Health
Questionnaire
(PHQ-9)
9 items; assesses depression severity.
Cronbach’s α = 0.86-0.89; sensitivity of 88%
and specificity of 88% for major depression
(Kroenke, Spitzer, & Williams, 2001).
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Data Analysis and Statistical Considerations:
Sample Size Calculation. The pilot study is powered on an intention-to-treat analysis of
mean change in A1C and diabetes self-care behaviors (SDSCA score), at 6 months as compared
to baseline. Sample size calculation is based on a two-tailed alpha level of 0.05, power of 0.8,
Life
satisfaction
Satisfaction with
Life Scale (SWLS)
5 items; measures global life satisfaction/
subjective well-being; Cronbach’s α = 0.82
(Diener, Emmons, Larsen, & Griffin, 1985).
Hypothesized Mediator
Habit strength See SDSCA above See SDSCA above
Problem
solving
Diabetes Problem-
Solving Interview
(DPSI)
Structured interview; probes for problem
solving strategies for hypothetical scenarios
(Toobert & Glasgow, 1991).
Activity
participation
Participation
Objective
Participation
Subjective (POPS)
26 items; measures participation frequency,
importance, and desired change; internal
subscale consistency 0.37-0.89 (Wilkie et al.,
2011).
Diabetes self-
efficacy
Diabetes
Empowerment
Scale-Short Form
(DES-SF)
8 items; measures psychosocial self-efficacy;
Cronbach’s α = 0.84 (Anderson, Fitzgerald,
Gruppen, Funnell, & Oh, 2003; Glasgow,
Toobert, Barrera, & Strycker, 2004).
Diabetes
knowledge
Diabetes
Knowledge
Questionnaire
(DKQ-24)
24 items; measures general diabetes
knowledge; Cronbach’s α = 0.78 (Garcia,
Villagomez, Brown, Kouzekanani, & Hanis,
2001).
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and 20% attrition. We estimate a 0.5% between-group difference in A1C (SD 1%), consistent
with previous meta-analyses of diabetes behavioral interventions (Gary et al.; Minet et al.;
Winkley et al.). A minimum clinically important difference for the SDSCA has not been
established; therefore we estimated a 20% change in SDCSA scores for blood glucose
monitoring and insulin/medication administration. Based on these parameters, a calculation using
G*Power software yielded an estimate of 44 participants (22 per group), which was revised
upward to 56 participants to account for attrition.
Descriptive statistics. Prior to conducting hypothesis tests, baseline characteristics will be
described using frequency distributions, histograms, and summary statistics. Skewed data on
signed change scores will be transformed to normalize distributions as necessary. Sparse data on
continuous measures may be recoded to dichotomous or ordinal data, and data will be examined
to identify outliers falling >2 SD outside the norm.
Primary analysis: The primary analysis will evaluate the hypothesis under Aim 1
(efficacy for mean change in A1C and diabetes self-care) on an intention-to-treat basis using a
Student’s t-test assessing between-group differences. Signed change scores will be calculated for
each variable by subtracting each participant’s baseline values from his or her post-intervention
values. To assess the robustness of these analyses, we will compare results including and
excluding outliers, and with and without imputed data, to assess whether these data are driving
the trend observed in the results. Additionally, we will conduct exploratory analyses using
ANCOVA methods to examine whether any demographic variables were effect modifiers which
should be considered as potential stratifying variables in a future large-scale RCT.
Secondary analyses: These analyses will evaluate hypotheses under Aim 2 (impact on
mean change in secondary outcomes and potential mediators). Because power calculations are
52
based on the primary analysis, secondary analyses will be considered exploratory only. Analysis
of secondary outcomes will investigate between-group differences in change on measures of
depression, life satisfaction, diabetes-related quality of life, and diabetes-related stress. Analysis
of potential mediators will assess between-group differences in changes on measures of habit
strength, problem solving, activity participation, diabetes knowledge, and diabetes self-efficacy.
Although the pilot study lacks power to test a full meditation model, we are seeking to learn
which mediators change as a result of the intervention. This data will facilitate power
calculations to evaluate mediating pathways using structural equation modeling in a large-scale
trial of the intervention.
Process evaluation analysis: This analysis will assess Aim 3, the evaluation and
refinement of intervention delivery and study procedures. Using both qualitative and quantitative
methods, we will assess whether the intervention and study procedures were executed as
intended, reasons for protocol deviations, and determine desirable enhancements to the
intervention for future research or clinical applications. Treatment fidelity will be analyzed with
respect to structure (e.g. number and length of sessions) and process (e.g. adherence to
intervention principles; deviations from intervention protocol). Quantitative analysis will include
descriptive statistics characterizing intervention delivery (attendance; dose of modular content).
Therapist interviews will be analyzed thematically to extract data on barriers to
implementation, reasons for protocol deviations, and applicability of the manual to clinical
problems. Participant focus group data will be analyzed thematically to assess subjective
impressions of the intervention’s impact on health and wellbeing, perceived mechanisms by
which the intervention had an effect, and carryover of intervention content in everyday life
53
situations. Collectively, this mixed methods analysis will result in a summary of intervention
implementation to guide future intervention delivery and evaluation.
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Chapter 3: Manual of Operations and Procedures for the REAL: Resilient,
Empowered, Active Living with Diabetes Intervention
UNIVERSITY OF SOUTHERN CALIFORNIA
DIVISION OF OCCUPATIONAL SCIENCE & OCCUPATIONAL THERAPY
MANUAL OF OPERATIONS & PROCEDURES
for the
REAL: Resilient, Empowered, Active Living with Diabetes Intervention
for Urban Minority Young Adults (REAL Diabetes Study)
IRB # HS-14-0032
ClinicalTrials.gov # NCT02214641
Study # 1K01DK099202-01A1
Date July 1, 2014
Version 1.0
PRINCIPAL INVESTIGATOR:
Elizabeth A. Pyatak, OTR/L, PhD, CDE
FUNDING AGENCY:
NATIONAL INSTITUTES OF HEALTH/
NATIONAL INSTITUTE OF DIABETES, DIGESTIVE AND KIDNEY DISORDERS
55
Table of Contents
1.1 Introduction to Study Protocol 57
1.2 Study Organization and Responsibilities 60
1.3 Training Plan 61
1.4 Communications Plan 68
1.5 Study Intervention 70
1.6 Recruitment Plan 72
1.7 Participant Retention 76
1.8 Study Flow 78
1.9 Screening and Eligibility Criteria 79
1.10 Informed Consent and HIPAA 84
1.11 Randomization 86
1.12 Blinding and Unblinding (Masking and Unmasking) 87
1.13 Study Measurements and Procedures 88
1.14 Safety Reporting 95
1.15 Study Compliance 96
1.16 Data Collection and Study Forms 97
1.17 Retention of Study Documentation 102
1.18 Data Management 103
1.19 Quality Control Procedures 105
56
1.20 Data and Safety Monitoring Activities 107
1.21 Study Completion and Closeout Procedures 108
1.22 Policies 110
1.23 MOP Maintenance 115
Appendix A. Protocol Deviation Log 116
Appendix B. MOP Modification Log 118
57
1.1 Introduction to Study Protocol
Type 1 diabetes mellitus (T1D) is the second-most common serious childhood disease in
the United States, while the incidence of type 2 diabetes mellitus (T2D) has increased markedly
among adolescents, with racial/ethnic minority populations at particularly high risk. Maintaining
control of diabetes is particularly difficult when these adolescents enter young adulthood. Young
adults with T1D have mortality rates 3-6 times higher than those without diabetes, and are at
elevated risk for mental health disorders, substance abuse, and diabetic complications. Less is
known about health outcomes for young adults with T2D, although preliminary studies suggest
an aggressive disease course, with more rapid onset of complications, and greater diabetes-
related stress and negative life events, than their peers with T1D or older people with T2D.
The reasons for poor health among young adults with diabetes are complex and
interrelated, including psychosocial issues, diabetes “burnout,” risk-taking behavior, competing
priorities, and the challenge of transitioning from pediatric to adult healthcare settings. Because
most diabetes care is performed by the individual in the context of everyday life, adherence to
self-care recommendations is vital to maintaining glycemic control. Studies evaluating
interventions to improve diabetes self-care in young adults have, overall, shown success in
reducing loss to medical follow-up, but not in improving glycemic control or psychosocial
outcomes. The proposed program of research and career development targets the needs of urban
minority young adults with poorly controlled diabetes – a group at particularly high risk for poor
health outcomes. Given existing interventions’ modest effects, the significant barriers to self-care
encountered by this group, and the likelihood of their incurring high healthcare costs, we posit
that an intensive, multifaceted intervention may be warranted to improve health in this
population.
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This study aims to address these issues by pilot-testing an innovative diabetes self-
management intervention, Resilient, Empowered, Active Living with Diabetes (REAL). The
REAL intervention was developed using the principles of an activity-based intervention,
Lifestyle Redesign, which has been shown to cost-effectively improve long-term physical and
mental health outcomes, and to be feasible and accessible to implement for a range of chronic
conditions in diverse populations. We will carry out a pilot randomized controlled trial involving
young adults with poorly-controlled diabetes (A1C ≥8.0%) recruited from LA County diabetes
clinics and emergency departments. Eighty participants will be randomized to receive either the
6-month REAL intervention or an attention control condition. We hypothesize that the
intervention will influence diabetes self-care and, in turn, glycemic control, by increasing
participants’ habit strength, problem solving, activity participation, diabetes knowledge, and self-
efficacy. Data will be collected at baseline and 6 months (post-intervention), and will include
assessment of general demographics, primary outcomes (A1C and diabetes self-care), secondary
outcomes (diabetes-related stress and quality of life, depression, and life satisfaction), and
hypothesized mediators. The study will be completed over a 3-year period including start-up and
recruitment, intervention delivery, data analysis, and dissemination of findings.
The proposed career development program positions Dr. Pyatak within a network of
successful mentors from diverse disciplinary backgrounds with expertise in the clinical
management of diabetes in ethnically diverse young adults, health behavior interventions for
minority youth, and randomized trials of diabetes self-management interventions. The career
development plan includes training in clinical trial management, statistical analysis, and process
evaluation of complex behavioral interventions. The highly supportive mentoring team and
institutional environment aim to equip Dr. Pyatak with the skills necessary to conduct large-scale
59
RCTs of complex interventions addressing the health and psychosocial needs of underserved
populations.
Aims and Hypotheses:
Aim 1. Determine the intervention’s efficacy for the primary outcomes: glycemic control and
diabetes self-care.
Hypothesis: At 6 months, intervention group participants will demonstrate improvements
in A1C and diabetes self-care as compared to control group participants.
Aim 2. Conduct exploratory analyses of the intervention’s impact on secondary outcomes and
potential mediating mechanisms.
Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements
in secondary outcomes: diabetes-related stress and quality of life, depression, and life
satisfaction as compared to control group participants.
Hypothesis 2: At 6 months, intervention group participants will demonstrate
improvements in potential intervention mediators: habit strength, problem solving, activity
participation, self-efficacy and diabetes knowledge as compared to control group
participants.
Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention
delivery and study procedures.
60
1.2 Study Organization and Responsibilities
[Redacted]
61
1.3 Training Plan
1.3.1 Intervener Training and Qualifications
The intervention will be provided by a licensed occupational therapist (OTR/L) with 20 hours of
training in the REAL intervention manual and 12 hours of training in motivational interviewing.
In addition, the OTR/L will have a minimum of 20 continuing education hours in diabetes
education within a year of initiating the intervention.
Interveners must also have current HIPAA certification and CITI training. Documentation of
intervener certifications will be kept on file and maintained by the project manager.
REAL intervention manual training (20 hours)
The REAL Intervention training will include the following components:
Review of principles and theoretical framework of intervention (4 hours)
Review of intervention modules (8 hours)
o Overview of module structure: 1 hour
o Review of each module: 7 hours (1 hour per module)
Integration with motivational interviewing and diabetes training (2 hours)
Role-playing and problem-solving challenging clients (4 hours)
Administrative issues, including treatment documentation, fidelity monitoring, safety and
adverse event reporting, iPad and text messaging protocols, general policies and
procedures (2 hours)
The objectives of in-house, intervention manual training sessions include:
- The therapist will apply and adapt theoretical principles that ground the REAL
intervention for use in a clinical setting.
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- The therapist will be proficient in the content of each intervention module, including
assessments, client learning objectives, and examples of activities.
- The therapist will identify goals congruent with a client’s identified diabetes care needs,
and develop treatment activities to achieve these goals.
- The therapist will apply the intervention manual to a client’s real-world setting, including
maintaining client centeredness through flexibility and adaptation, while maintaining
fidelity to the intervention protocol.
- The therapist will adapt handouts into hands-on activities, through which the client is
actively engaged in occupations and not simply recalling learning material.
- The therapist will employ the iPad and text messaging as technological tools to assist
with intervention activities and sessions, as necessary.
- The therapist will implement appropriate steps when faced with a situation which he/she
needs assistance (i.e., client mental or physical emergency, break in protocol, questions
surrounding manual fidelity, etc.).
- The therapist will navigate through RedCap in order to enter clinical documentation in a
standardized format.
- The therapist will demonstrate understanding of administrative policies and procedures.
Diabetes Education (20 hours)
- Continuing education in diabetes management may include any continuing education
course recognized by the NCBDE Recognized Provider List
(http://www.ncbde.org/currently_certified/recognized-provider-list/) which addresses, at
minimum, the following topics:
63
o Natural history and pathophysiology of pre-diabetes, type 1 diabetes, type 2
diabetes, and gestational diabetes.
o Healthy eating and dietary recommendations for persons with diabetes or at risk
of acquiring diabetes.
o Activity and physical exercise recommendations for persons with diabetes or at
risk of acquiring diabetes.
o Types, tools, frequency, and targets of monitoring for persons with diabetes.
o Clinical assessment, including blood glucose monitoring, foot examination, and
depression screening.
o Medication use in persons with diabetes, including insulin, oral diabetes
medications, and medications commonly prescribed for comorbid conditions.
o Strategies to promote healthy coping for persons with diabetes.
o Approaches to reduce health risks (smoking cessation, cardiovascular risk
reduction) in individuals with diabetes.
o Strategies for goal setting and behavior change in accordance with psychosocial
needs and cultural beliefs.
- Continuing education courses may be completed either online or in person, although in-
person training is preferred.
- Two courses which meet the above criteria, and are recommended for therapists
administering the REAL intervention, are the AADE Core Concepts course (3-day live
course or 9-week online course) or the Scripps-Whittier Comprehensive Diabetes
Education and Management Program (5-day live course).
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Motivational interviewing training:
12 hours of motivational interviewing training will be provided to REAL personnel by an MI
trainer certified with the Motivational Interviewing Network of Trainers (MINT). The training
materials, goals, and objectives will be retained for refresher trainings of personnel throughout
implementation of the REAL intervention.
1.3.2 Research assistant training
Research assistants will receive paid training on the topics listed below, prior to commencing
work. In addition, all research assistants must either submit current HIPAA and CITI/IRB
training documentation, or complete both HIPAA and CITI training, prior to performing any
duties as part of the study team.
- Administrative information (certifications, forms and timesheets, mileage)
- Participant privacy and confidentiality
- Questionnaire administration
- Adverse event reporting
- Participant tracking and scheduling
- Data entry
- Control intervention delivery
- Documentation and communication procedures
1.3.3 DPSI training
The initial DPSI scoring training will be conducted via videoconference with the assessment
developer, Deborah Toobert. The initial training will consist of 6 hours and will include
review of the following:
65
Administration of the assessment
Review of coding procedures
Review of coding decisions/judgments
Strategies for resolving coding discrepancies/maintaining reliability
Subsequent to the initial training, the PI will retain the original training materials. The PI will
personally conduct subsequent trainings or delegate trainings to a graduate research assistant
proficient in the DPSI coding system.
1.3.4 HIPAA/IRB
Below are instructions for completing USC's online HIPAA Education Program and CITI
(Human Subjects Protection) certifications. Both certifications must be completed by all
personnel prior to being added to the REAL Diabetes Study team. Certificates must be saved in
the REAL DIABETES/Administrative/HIPAA-CITI folder on the Shared (S:) drive.
Please reference the HSC IRB webpage: http://www.usc.edu/admin/provost/oprs/hsirb/
1. Establish an iStar username. (You will need to input your iStar username during the
registration process so that all certificates can be automatically uploaded to your iStar
account). If you do not already have an iStar username, go to the Quick Link section of
the above website and click on iStar, then click on “Obtaining an iStar Account” on left
side of page. (NOTE: CITI will not recognize your iStar username until you "Register for
the CITI Course")
1. From the HSC IRB page, click on CITI from the Quick Link section and follow the "CITI
Login and Registration Page" instructions.
2. Choose “New Users” and register
66
3. Under the “All Others” drop down menu, locate University of Southern California and
highlight. Click the “submit” button
4. Choose a username and a password. Click the “submit” button.
5. Fill in the required fields in the registration form. Fill in your department and category.
We are in Occupational Science and Occupational Therapy (Division 7) on the HSC
campus in behavioral research.
6. Select a group appropriate to your research activities & role.
7. You may start and stop the course at any point of the course.
8. Follow the similar instructions for HIPAA Education Program (Office of Compliance)
and GCP links.
9. Contact the OPRS at (213) 821-1154 or oprs@usc.edu if you have questions.
Please note: GCP & USC HIPAA are a one-time only course. The CITI will need to be renewed
every 3 (three) years.
1.3.5 Bloodborne Pathogen Training
Below are instructions for completing USC's online Bloodborne Pathogen Training
certification. This must be completed by all personnel who will be conducting A1C testing prior
to being added to the REAL Diabetes Study team. Certificates must be saved in the REAL
DIABETES/Administrative/HIPAA-CITI folder on the Shared (S:) drive.
1. From the CITI main page, choose “Click here to affiliate with another institution.”
2. In the Search box, enter Southern California and select “University of Southern
California – Safe Laboratory Practices Courses”
67
3. On the CITI main page, under “University of Southern California – Safe Laboratory
Practices Courses” click “add a course or update learner groups”
4. Scroll down to “OSHA Bloodborne Pathogens,” check the box, and then hit “Next” at the
bottom of the screen.
5. Within the Bloodborne Pathogens course, complete all the required modules, and the
“Work Safely with Sharp Instruments” module.
68
1.4 Communications Plan
1.4.1 Research team meetings
Weekly
Attendees: All unblinded student workers, research support staff (e.g., doctoral-level
research assistants; project manager), PI.
Recording of minutes and action items: project manager
1.4.2 Therapy team meetings
Weekly
Attendees: Occupational therapist(s) delivering intervention; project manager; doctoral-
level research assistants; PI.
Recording of minutes and action items: project manager
1.4.3 Mentoring meetings
One-on-one mentoring meetings with Dr. Peters (monthly)
Attendees: Drs. Peters and Pyatak; research support staff as needed.
Recording of minutes and action items: Dr. Pyatak
Mentoring team meetings (monthly; alternate with one-on-one meetings)
Attendees: Drs. Peters, Whittemore, Spruijt-Metz, and Pyatak; research support staff
as needed.
Recording of minutes and action items: Dr. Pyatak
Every six months, the mentoring meeting will be a formal progress evaluation for Dr.
Pyatak’s career development. During this meeting, Dr. Pyatak will formally present
69
her research and training progress over the previous six months to the mentoring
team. They will then hold a private discussion regarding her strengths and areas for
improvement, and share feedback from this discussion, along with specific strategies
to accelerate her progress, at the conclusion of the meeting.
1.4.4 DSMC meetings
Biannual
Report of recruitment, intervention and study implementation
1.4.5 Community Advisory Board
Includes consumers, advocacy group members, clinicians by invitation from PI
Closed Facebook Group
Invite selected member(s) to attend DSMC meetings as community representative
1.4.6 Communication with NIDDK
Annual progress report
Formal protocol changes
Notification of publications and presentations
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1.5 Study Intervention
1.5.1 REAL Intervention implementation
The REAL intervention will be delivered over a 6-month period.
Typically, the intervention will be delivered in 12 biweekly sessions lasting about one hour
each. However, the timing and duration of sessions may be modified, at the therapist’s
discretion, if more appropriate for attainment of the participant’s individualized goals.
In-person contact hours will be tracked on an ongoing basis, and must fall into the range of 10-
16 hours per participant.
Sessions should be delivered, to the greatest extent possible, in participants’ homes or other
sites in their local communities. If necessary, office space will be made available in the CHP-
101 conference room or other suitable space.
Interveners should adhere to guidelines in the current version of the Intervention Protocol,
maintained in the REAL STUDY/REAL-INTERVENTION/Therapist Manual folder on the S:
drive, including guidelines regarding text messaging, the role of consultants, strategies for
individual tailoring and other issues pertaining to intervention.
1.5.2 Information condition
Participants randomized to the information condition will receive a packet of standardized
educational materials, which will be delivered to the participant in person by a graduate student
worker. Subsequently, at approximately 2-week intervals, the graduate student worker will provide
follow up phone calls to ask the participant if they have reviewed specific parts of the packet and
answer any questions related to the educational materials. The student workers delivering the
information intervention will be blinded to the study outcome measures.
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Documentation Procedures: Information intervention home visits, mailings, and phone
calls will be tracked in the RedCap “REAL Participant contact and scheduling” log. Each
attempted contact (whether successful or unsuccessful) must be documented to maintain
accurate study records.
Information Intervention Delivery: Data collectors will adhere to the guidelines and phone
script outlined in the “Control Group Guidelines” saved in the REAL STUDY/REAL –
RESEARCH/Control Group Materials folder.
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1.6 Recruitment Plan
Participants will be recruited through the following strategies:
(1) Personal contact with study staff during an on-site clinic visit (with completion of
recruitment procedures at the clinical site or with later follow-up);
(2) Receipt of a personal phone call, email, or letter delivered by study staff (when contact
information is forwarded by the clinical site with prior approval from the prospective
participant, or potential participants are identified in a clinic’s database);
(3) Exposure to a flyer that contains a description of the research opportunity along with
study contact information.
1.6.1 Recruitment Criteria
Table 3.1 Recruitment Criteria
Inclusion Criteria Exclusion Criteria
Age 18-30 (inclusive) at time of
enrollment
Pregnant or planning to become pregnant
within the next 6 months
Fluent in English or Spanish
Participant in a diabetes-related lifestyle
intervention within previous 12 months
Diagnosis of T1D or T2D for ≥12
months
Participant in research related to
intervention development
A1C ≥8.0% at last clinic visit or per
point-of-care assay at study enrollment
Cognitive impairment or severe
disability limiting life expectancy
Resident of Los Angeles County with no
plans to relocate within 12 months
Can be reached by phone or text message
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Willing to participate in study activities
Patient at LAC-USC, and/or Household
income <133% of Federal Poverty Level
and/or qualifies for any of the following
services: ORSA, CCS, MediCal,
EBT/Food Stamps, WIC, CalWORKS,
CalFresh
1.6.2 Recruitment Sites
Five recruitment sites have agreed to participate in the study:
1. LAC+USC Pediatric Diabetes Clinic (primarily on-site recruiting)
2. LAC+USC Young Adult Diabetes Clinic (primarily on-site recruiting)
3. Children’s Hospital Los Angeles diabetes clinic (primarily on-site recruiting)
4. LAC+USC Young Adult Emergency Department (primarily chart review/contacting
prospective participants by phone or mail)
5. Roybal Diabetes Management Program (primarily chart review/contacting prospective
participants by phone or mail)
1.6.3 Recruitment Methods
Screening
Three primary methods of screening will take place, depending on how participants are recruited.
1. Participants identified during on-site clinic visits will have their medical records
reviewed prior to approaching the participant; self-reported eligibility criteria will be
gathered in person prior to consenting.
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2. Participants referred by healthcare providers or by clinic records will have
preliminary eligibility verified by the referring healthcare provider or medical records
at the time of screening; self-reported eligibility criteria will be gathered in person
prior to consenting.
3. Participants responding to a flyer will have a preliminary screening and review of
eligibility criteria by phone at the time initial contact is made. A1C will be assessed at
time of in-person completion of study enrollment forms. Other criteria requiring
review of medical records will take place after participant has completed enrollment
forms and consented to medical record review.
Enrollment
Enrollment may take place on site at participating recruitment sites, or at an individual’s home.
Prospective participants may talk to an on-site study recruiter at the clinic, have their contact
information provided to study personnel to follow up at a later time, or initiate contact with study
personnel themselves based on viewing a flyer or other recruitment materials. For participants
expressing interest in enrolling in the study, a recruiter will discuss all relevant aspects of the
study with the prospective subject, and will obtain informed consent if the prospective subject
wishes to enroll. An in-person appointment will be made (at the prospective participant’s home
or other location of choice) to finalize the consent process for individuals who do not complete
enrollment on-site during a clinic visit.
Apart from recruiting persons through direct contact, individuals who are identified through
clinic records as potentially eligible will be contacted by study personnel via a letter or phone
call. If a given individual potentially qualifies for study entry and appears interested in
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participating, then the recruiter will schedule a face-to-face meeting, at the location of the
individual’s choice, to obtain informed consent. The two-step process of initial phone contact
followed by an in-person meeting will also be used to obtain consent from individuals who
telephone the recruiter in response to a flyer that describes the study, which will be posted on-
site at participating clinics.
Individuals who choose to enroll in the study will be randomized to condition shortly following
baseline testing and verification of eligibility criteria through chart review. If it is determined
that that the individual is not eligible, he/she will be provided with information about diabetes
care through a mailed brochure and a personal phone call. He/she will also receive compensation
for baseline testing if this was completed. The need to pass these screens prior to official study
enrollment will be explained by the recruiter and described on the consent form.
Informed Consent/HIPAA
Informed consent will be obtained by having a staff member carefully explain the research study
and then read or paraphrase the entire consent form with the prospective participant. The
prospective participant will have an opportunity to ask questions about the study. Individuals
who choose to enroll in the study will sign the consent form and be provided with a copy.
Participants will also review and sign a HIPAA Authorization for Use or Disclosure of Health
Information Form to permit study personnel to review their medical records to verify eligibility
and obtain information on their current treatment regimen, comorbid conditions and diabetes
complications. They will also be given a copy of the Research Subject’s Bill of Rights.
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1.7 Participant Retention
Several steps will be taken in an effort to retain participants over the course of the study, without
coercion. These ongoing efforts include the following:
Collecting multiple sources of contact information at enrollment:
o The participant’s address, email, cell phone and alternate phone;
o Email and phone numbers for an alternate friend/family contact;
o Email and phone numbers for an emergency contact
Contacting participants frequently:
o Intervention participants will have in-person visits approximately once every
two weeks with optional text message contact in between visits,
o Control participants will receive mailings and phone calls each week, in
alternate weeks.
Maintaining updated information: At each scheduled contact, participants will have
an opportunity to provide study staff with updated contact information.
If the study design is modified to include a long-term follow-up (6 months without
contact from the intervention and/or control staff), the following measures will be
enacted to maintain contact between the end of the intervention and the follow-up:
o Participants will receive monthly phone calls or text messages during the
follow-up period to maintain updated contact information.
o Participants will receive a reminder postcard one month before their scheduled
follow-up testing.
o Participants will receive a $50 stipend for follow-up testing, to maximize the
incentive for completion.
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If retention problems develop during the course of the study (e.g., greater than 20% of
participants become unreachable at some point during the intervention), the following
corrective steps will be taken:
Consultation with the study’s community advisory board regarding possible reasons
for poor retention and possible solutions
Consideration of increased stipends to ensure greater participation
Collaborating with clinical sites to access updated contact information for participants
lost to follow-up.
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Figure 3.1. Study Flow Diagram
1.8 Study Flow
Figure 3.1 below illustrates the study flow for participants enrolling in the REAL Diabetes
Study.
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1.9 Screening and Eligibility Criteria
Figure 3.2 Screening and Enrollment Process
There are four stages to screening and enrollment, as outlined in the figure above. Prescreening is
the process of limiting the scope of who will be screened. This includes performing queries in an
electronic medical record system to limit records for review according to patients’ age and
diagnosis, as well as returning phone or email queries from interested individuals or clinicians.
Prescreening activities that do not collect personally identifying information are not logged.
At the time an individual’s personally identifying information is reviewed (in a medical record, in
person, or over phone/email), the individual is considered “screened” and their information must
be entered into the Screening Log. At this point a provisional determination is made as to whether
the person is eligible for the study.
If the person is ineligible, this is noted in the Screening Log and no further action is taken.
If the person is provisionally eligible, based on available information, their information
is recorded in the Screening Log and they are approached to offer study participation.
o If the person declines or is lost to follow-up, this information is noted in the
Screening Log and no further action is taken.
o If the person agrees to participate, the Eligibility Checklist is completed.
Prescreening
•Limiting scope of
records to
review: e.g.,
search query in
medical record
review
Screening
•Complete
Screening Log
for anyone
whose personal
information is
reviewed
Eligibility
•Complete
Eligibility
Checklist for
anyone who is
approached to
participate in the
study
Enrollment
•Once eligibility is
established,
participant is
enrolled and
completes:
•Informed Consent
•HIPAA
•Contact
Information
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If the person is determined to be ineligible after completing the Eligibility
Checklist, this is noted on the Screening Log and no further action is taken.
If the person is determined to be eligible after completing the Eligibility
Checklist, proceed to enroll the participant (fill out Informed Consent,
HIPAA, and Recruitment Questionnaire). Note the date of enrollment on the
Screening Log.
1.9.1 Screening Log
All individuals screened for study inclusion will be recorded in the Screening Log.
This includes individuals screened on-site at clinics, individuals screened through
medical chart review, and individuals who contact the study office.
Research assistants performing off-site recruitment should take blank copies of
Screening Log forms with them and return to the study office the same day, if
possible, and no later than the next business day. A research assistant will enter
Screening Log entries into the database on a weekly basis. Following data entry, hard
copies will be stored in a locked filing cabinet in the PI’s office.
1.9.2 Eligibility Criteria
Participants must meet eligibility criteria outlined in the Eligibility Checklist
(included below). All responses must fall in the shaded column for a participant to be
eligible for the study. Preferred data sources for determining eligibility are BOLDED
in the checklist below. If unavailable, secondary mechanisms may be used, with a
note indicating the reason that the preferred/primary data source was not available.
Item 11, participation in previous REAL Diabetes Study research, includes only
qualitative interviews (not the validation study; this would fall into category 10:
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previous diabetes management intervention). Qualitative interviews were completed
with 20 young adults with type 1 diabetes and 8 young adults with type 2 diabetes,
typically in their home. If a participant is unsure whether they were interviewed by
one of the three named individuals, this should be reviewed by the PI.
Table 3.2. Eligibility checklist
Inclusion Criteria: Response Data source
1. Participant’s Age
(DOB: ___/___/______)
≤ 17 yrs. old
≥ 31 yrs. old
18-30 yrs.
old
Medical
Record
Self-Report
2. Date of diabetes diagnosis
(Type 1 / Type 2)
Month/Year: ___/_______
□ < 12 months
since dx
□ ≥ 12 months
since dx
□ Medical
Record
□ Self-Report
□ Other:
3. Most recent A1C (Date:
___/___/______) Results:
_________%
For participants for whom A1C is not a
reliable indicator of glycemic control
ONLY:
Fructosamine: __________ umol
Average SMBG: _________ mg/dl
□ < 8.0%
□ Fructosamine
< 325umol
□ Average
SMBG
< 180 mg/dl
□ ≥8.0%
□ Fructosamine
> 325 umol
□ Average
SBMG
> 180 mg/dl
□ Medical
Record
□ Point-of-
Care
4. Cognitive disability or severe
impairment limiting life expectancy**
□ Yes □ No
□ Medical
Record
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□ Observation
5. Are you fluent in English or Spanish?
(preferred language: __________)
No Yes
Self-Report
Other:
6. Can you be reached by telephone or
text message?
No Yes
Self-Report
Other:
7. Are you able to participate in study
activities such as assessments and
home visits?
No Yes
Self-Report
Other:
8. Do you live in LA County with no
immediate plans to relocate?
No Yes
Self-Report
Other:
9. Are you pregnant or planning to get
pregnant?
Yes
No
N/A (male)
Self-Report
Other:
10. Have you had an intervention to help
with your diabetes in the last 12
months?
Yes No
Self-Report
Other:
11. Were you interviewed by Sergio
Sandoval, Daniella Florindez, or Beth
Pyatak for another diabetes study?
Yes No
Self-Report
Review by PI
12. [NOT REQUIRED FOR COUNTY
PATIENTS] Is your household income
less than the amount shown below, OR
do you qualify for any of the following
programs: ORSA, CCS, MediCal,
No
Yes
N/A
(County)
Self-Report
Other:
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EBT/Food Stamps, WIC, CalWORKS,
CalFresh
**"Severe disability limiting life expectancy" includes:
Patients in end-stage renal failure, defined as currently being on dialysis,
or projected to go on dialysis within the next 12 months (per physician's
opinion)
Patients with advanced complications or comorbidities that limit participation in
everyday life activities (inc. ADLs, work/school, and leisure). This is somewhat
more subjective and will be evaluated by PI & mentors on a case-by-case basis.
It probably would not exclude someone with blindness or neuropathy who is still
able to participate in everyday life activities. It probably would exclude someone
with advanced gastroparesis on a feeding tube as this is a limitation in a major
life activity.
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1.10 Informed Consent and HIPAA
Participants recruited at clinical sites may complete the Informed Consent and
HIPAA forms at the clinic, or a subsequent face-to-face meeting scheduled at a time
and place of the participant’s choice. Individuals recruited by phone or other means
will complete the Informed Consent and HIPAA at a face-to-face meeting scheduled
at their convenience.
Participants should be provided with a copy of the Informed Consent, Research
Subject’s Bill of Rights, and HIPAA authorization for their records at the time
of providing informed consent.
1.10.1 Informed Consent
Informed consent will be obtained by having a project staff member carefully
explain the research study and then read (or paraphrase) the entire informed
consent form to the prospective participant. The prospective participant will have
an opportunity to ask questions about the study. Both the participant and the staff
member obtaining informed consent must print, sign, and date the informed
consent form. This form will be returned to the office and stored in a locked
filing cabinet in the PI’s office.
1.10.2 HIPAA Authorization
Participants will also review and sign a HIPAA Authorization for Use or Disclosure
of Health Information Form to permit study personnel to review their medical records
to verify eligibility and obtain information on their current treatment regimen,
comorbid conditions and diabetes complications. The participant must print, sign
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and date the HIPAA Authorization. This form will be returned to the office and
stored in a locked filing cabinet in the PI’s office.
1.10.3 Certificate of Confidentiality
A certificate of confidentiality for the study has been issued by the NIH/NIDDK. A
hard copy is kept in Beth Pyatak’s office. In the event that the study will not be
completed by the expiration date (4/30/2017) an extension should be requested by
contacting Francisco O. Calvo, PhD, Chief, Review Branch, National Institute of
Diabetes and Digestive and Kidney Disease.
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1.11 Randomization
Randomization Plan: Randomization is stratified by type of diabetes (type 1 or
type 2). The study statistician (Cheryl Vigen) first generated random block sizes
with probabilities of 25%, 50% and 25% for sizes of 2, 4, and 6, respectively for
type 1 diabetes and probabilities of 15%, 35%, 35% and 15% for sizes of 2, 4, 6,
and 8 for type 2 diabetes. Within each stratum and block, equal numbers of
participants are assigned to each of the two treatment groups in random order.
Process Responsibilities: The master randomization list was generated by a SAS
program which, along with the randomization list, is securely maintained on the
study statistician’s network drive. The randomization list was uploaded to the
REDCap database management system which automatically assigns treatment
group to participants when the Eligibility Checklist form is completed.
Randomized assignment is available only to specified study personnel through the
REDCap system.
Procedure for Randomizing a Participant: Participants are randomized within the
REDCap Participant Contact and Scheduling database. Specifically, after
completing all enrollment procedures and baseline testing, the randomization
module in the Eligibility Checklist form is utilized to randomly assign participants
to the correct group in accordance with the randomization list uploaded into the
REDCap database management system.
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1.12 Blinding and Unblinding (Masking and Unmasking)
In lifestyle and behavioral interventions, is it not possible to blind participants and
therapists regarding what intervention they are receiving. However, the following
blinding measures will be undertaken:
Individuals who conduct assessments will be blinded to condition assignment.
In the case of baseline testing, this will occur prior to randomization. For post-
testing, participants will be instructed when testing is scheduled not to tell the
assessor which intervention they received.
The primary treating occupational therapist, and graduate student workers
delivering the control intervention, will be blinded to the outcome measures
used to evaluate participants.
Individuals involved in data analysis (including the PI, mentors, doctoral level
research assistants and biostatistician) will conduct analyses using de-
identified data.
88
1.13 Study Measurements and Procedures
Three discrete testing sessions will take place in the study, in addition to the
screening and enrollment procedures. These include assessment packets at baseline
and 6 months (immediately following completion of the intervention), and at
approximately 7 months, when participants complete a qualitative interview/focus
group and study exit survey. To ensure that assessments and measures are conducted
consistently, this section describes procedures for performing assessments and
outcome measures. For detailed instructions on completing study forms, refer to
Section 1.16, Data Collection and Study Forms.
1.13.1 Timeline and Visit Schedule
Table 3.3. Timeline and Visit Schedule
Visit Description Screening
Enroll-
ment
Treatment Phase
Follow
-up
Study Visit/Study
Month
Baseline Ongoing
6
months
7
months
Screening Log X
Eligibility Checklist X
Informed Consent X
HIPAA X
Background
Questionnaire
X
Medical Chart
Review
X
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Table 3.3. Timeline and Visit Schedule
Visit Description Screening
Enroll-
ment
Treatment Phase
Follow
-up
Study Visit/Study
Month
Baseline Ongoing
6
months
7
months
A1C X X
ADD-QOL X X
CAGE-AID X
CCA X
DES-SF X X
DKQ X X
DPSI X X
PAID X X
PHQ X X
POPS X X
SDSCA X X
SWLS X X
Adverse Events X X X X X X
Focus Group/
Interview
X
Study Exit Survey X
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1.13.2 Study Visits/Data Collection Points
Screening: At this stage, we are collecting data on people who may or may not become a
part of the study. No personal identifiers are collected in the screening log. Data for
each person who is screened (considered for potential inclusion in the study), whether
in person, over the phone/email, or through medical record review, should be logged
in the screening log. Participants who are eligible and agree to participate should be
assigned a study ID at that time. For this reason, the list of current study ID numbers
should be
For people not excluded at the screening stage, an eligibility checklist should be
completed. The eligibility checklist contains personal identifiers (initials and date of
birth) and therefore should be filed with consent forms and HIPAA authorizations
(for enrolled participants) or destroyed (for non-enrolled participants). All responses
on the eligibility checklist must fall in the gray column for the participant to be
eligible to enroll.
Enrollment: At this stage, four forms are completed: The informed consent and HIPAA
authorization, the background questionnaire and the medical chart review.
The first form to complete is the informed consent. The second form to complete is
the HIPAA authorization. In completing these forms, adhere to procedures
described in section 1.6.3: Enrollment. Ensure that the participant receives a copy of
the Informed Consent and HIPAA authorization to keep for their records.
After completing the informed consent and HIPAA authorization, complete the
Background Questionnaire in full with the participant. Then, if possible, schedule
an appointment for baseline testing.
91
The Medical Chart Review form must be completed prior to randomization because,
if the participant is assigned to the intervention group, the treating therapist must have
access to these records prior to the first visit.
If the chart review cannot be completed at the time of enrollment, the recruiter should
schedule a time to access the participant’s medical chart within two weeks of
completing enrollment procedures with the participant.
Baseline testing
Timing: Baseline testing should be completed within two weeks of enrollment.
Participants should be called at least once every two days after their enrollment date
in an attempt to schedule testing.
Assessments: At this stage, the participant’s A1C is assessed using a finger-stick
blood draw, and eleven surveys will be completed by the participant.
Location: Testing should take place in the participant’s home or another location of
their choosing. It should be private and have access to an electrical outlet. If the
participant cannot identify such a location, baseline testing may (as a last resort) be
completed at the study office in the CHP-101 conference room.
Criteria for dropping participants at enrollment or baseline testing:
Once baseline testing and randomization are completed, participants must be
followed to the end of the study. Therefore, if enrollment or baseline testing sessions
are excessively difficult to schedule, we reserve the right to drop the participant from
the study prior to randomization. If either of the following criteria are met, the
participant will be dropped from the study:
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o Phone disconnection: If the participant’s main contact number is disconnected
when trying to schedule enrollment or baseline testing, they should be called once
more within 48 hours. If the phone remains disconnected, the participant will be
dropped from the study.
o Cancelling appointments: If the participant schedules testing three times without
completing testing, he/she will be dropped from the study. This includes testing
not completed because the participant calls to cancel, or because the participant is
a no-show at the appointment.
6-month testing:
Timing: Participants must complete the intervention within 6 months of baseline
testing. Testing should be scheduled as soon as possible after the 6-month date has
passed, and no later than 6 weeks after this date. Participants should be called one
week prior to their 6-month date in an attempt to schedule testing as soon as possible
after the 6-month date.
Assessments: At this stage, the participant’s A1C is assessed using a finger-stick
blood draw, and nine surveys will be completed by the participant.
Location: Testing should take place in the participant’s home or another location of
their choosing. It should be private and have access to an electrical outlet. If the
participant cannot identify such a location, baseline testing may (as a last resort) be
completed at the study office in the CHP-101 conference room.
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Interview/Focus Group and exit survey:
Timing: Interview/focus group participation and exit survey completion can occur
only after 6-month testing is complete. It should take place any time after that date,
but within 3 months of completing the intervention (9 months after baseline testing).
Assessments: The participant will be invited to attend a focus group or interview to
discuss their study experiences. The focus group or interview will follow a structured
post-intervention interview guide, and will be audiotaped. When the participant
completes the focus group and/or interview, they will be asked to complete a brief
exit survey. If the participant declines to attend an interview/ focus group session, the
exit survey should be mailed to them. Up to four reminder calls should be made
following the mailing of the exit survey. If the participant chooses, he/she may
answer the exit survey questions via phone rather than mailing the completed survey.
Location: Focus groups will take place at the CHP building, in the CHP-101
conference room or another comfortable location. If participants are unable to attend
a scheduled focus group, an interview can be completed either over the phone, or in
their home, or another location of the participant’s choosing.
1.13.3 Final Study Visit/Early Discontinuation Evaluations
Participants should be actively followed through all study visits until the final visit.
Any participant may request to discontinue the intervention (either the OT
intervention or attention control) for any reason. The date and reason for
discontinuing the intervention should be documented in RedCap. Participants who
discontinue the intervention will still complete all data collection visits.
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Any participant who expresses interest in withdrawing from the study must do so in
writing, and/or speak personally with the PI (in person or over the phone). If the
person requests withdrawal from the study, we should attempt to schedule an early
discontinuation visit. At this visit, the participant should be asked to complete an A1C
measurement, as well as the SDSCA and Study Exit form. If the participant shares
any feedback regarding their study participation, this data should be recorded in
RedCap. The participant should be thanked for their participation, and no further
contact will be made unless requested on the Study Exit form.
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1.14 Safety Reporting
All study personnel will be trained in the reporting of adverse events, serious adverse
events, and unanticipated problems. Event reporting forms are saved in the REAL
STUDY/REAL – ADMINISTRATION folder.
The PI and project coordinator will be jointly responsible for handling reports from
study personnel and reporting them, as appropriate, to the study’s DSMC, the USC
IRB, and NIDDK personnel as appropriate.
Safety reporting guidelines are outlined in the Adverse Events Protocol saved in the
REAL STUDY/REAL – ADMINISTRATION folder.
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1.15 Study Compliance
Protocol deviations can seriously compromise the integrity of the study, and every
effort should be made to adhere to the study protocol. However, inevitably,
circumstances arise where a study team member may inadvertently or intentionally
deviate from the study protocol. Maintaining accurate records of these protocol
deviations is critical. They should be reported to the PI and project manager within 24
hours of their occurrence (if possible) or as soon as they are discovered.
Protocol deviations include events such as the following:
Breach of confidentiality or other adverse event;
Randomization of an ineligible participant;
Failure to obtain Informed Consent or HIPAA authorization;
Failure to keep IRB approval up to date;
Wrong treatment administered to participant;
Outcome measurement not performed
A more comprehensive list of protocol deviations is included in the Protocol
Deviation Log (Appendix A).
Any study team member who commits, or learns about, a deviation from the study
protocol should report the deviation to the project manager and/or PI in writing within
24 hours.
The project manager and/or PI will record the protocol deviation in Appendix A of
the MOP. Protocol deviations which are also adverse events will be reported to the
IRB in accordance with the adverse event procedures. Otherwise, deviations will be
reported to the study’s DSMC at its biannual meetings.
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1.16 Data Collection and Study Forms
1.16.1 Source Documentation
A source document is any document on which study data are initially recorded. These
include assessments administered at enrollment (Background Questionnaire, Medical
Chart Review), baseline and post-testing (A1C data; paper-and-pencil surveys), and
other time points (adverse event reports; study exit survey). Information recorded on
source documents are input into RedCap for future data analysis; hard copies of
source documents are then retained in the study office.
1.16.2 Study Forms
BLANK study forms are available on the S: drive for printing. Forms should be
printed two-sided in black and white, preferably from OT-Printer07 (main CHP-101
office printer). Forms are stored in the following folders on the S: drive:
Screening and enrollment: REAL – RESEARCH/Recruitment & consent
forms
Baseline, post-testing, and focus group/study exit forms: REAL –
RESEARCH/Assessments
Adverse event reporting: REAL – ADMINISTRATION/Safety & Adverse
Events
Hard copies of BLANK study forms are available in the study office as follows:
Screening and enrollment forms: Recruitment packets maintained by study
recruiters
Baseline and post-testing forms: File folder in data collector/data entry
workstation
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COMPLETED study forms should be filed as follows:
Input Background Questionnaire and Medical Chart Review data into RedCap
immediately upon returning to the study office, before filing forms.
Forms which include PERSONAL IDENTIFIERS (Informed Consent;
HIPAA authorization; Background Questionnaire; Medical Chart Review) are
stored in the PI’s office. Hard copies should be left in the wall file outside the
PI’s office for filing.
Forms which do not contain identifiers should be filed in the filing cabinet in
the Data Collection/Data Entry workstation, in the file marked “to be entered”
Forms in the “to be entered” folder will be entered into RedCap during the
data collector’s next data entry shift; A1C and SDSCA forms will then be put
in the “to be double-entered” folder.
Forms other than A1C and SDSCA will be filed under the participant’s ID
number in the filing cabinet in the CHP-101 hallway. A1C and SDSCA will
be filed under the participant’s ID number after double data entry.
Table 3.4. List of REAL Study Forms
Form Name
Personal
Identifiers?
Description
Screening Log N Information on people screened for eligibility in the
REAL study
Eligibility Checklist N Checklist to determine if participants meet all inclusion
and exclusion criteria
Informed Consent Y Form describing risks and benefits of study
participation
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HIPAA Y Form allowing REAL study to access participants’
medical records
Contact
Information
Y Form containing participant’s name, DOB and contact
information
Medical Chart
Review
N
Form describing participants’ medical history
Demographic
Questionnaire
N
Form providing participants’ demographic information
ADD-QOL N Survey – diabetes-dependent quality of life
CAGE-AID N Survey – use of alcohol and drugs
CCA N Survey – childhood trauma and adversity
DES-SF N Survey – diabetes empowerment/self-efficacy
DKQ N Survey – diabetes knowledge
DPSI N Survey – diabetes problem-solving
PAID N Survey – diabetes distress
PHQ N Survey – symptoms of depression
POPS N Survey – participation in everyday activities
SDSCA N Survey – participation in diabetes self-care activities
SWLS N Survey – satisfaction with life
Adverse Events N Form describing any physical, psychological, social or
economic harm which the participant experienced,
regardless of its relationship to the participant’s study
involvement.
Study Exit Survey N Survey – participant’s satisfaction with study and future
contact information
1.16.3 General Instructions for Completing Forms
When completing study forms, PRINT IN CAPITAL LETTERS using black ink.
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Header: Complete the header information on EVERY page, including pages for
which no study data are recorded.
Participant ID: The participant ID must be recorded on EVERY page, including
pages for which no study data are recorded. Never include personal identifiers
(e.g. name, MRUN, SSN) on any study forms unless specifically indicated.
Date & Time: Include month, day, and year (e.g. 3/21/2014) required, unless
otherwise specified. Use a 24-hour clock (e.g., 14:00 to indicate 2 p.m.) unless
otherwise specified.
Abbreviations: Use of abbreviations not specifically noted in the instructions for
completing the forms can be problematic and should be held to a minimum.
Correcting errors: If an error has been made on the study forms, place a single
line through the erroneous entry and record the date and your initials. Indicate the
correct response.
Skipping items: Do not skip any items. Some items may carry "Unknown" or
"Not Applicable" response choices which should be selected when necessary.
Incomplete data: Data may not be available to complete the form for various
reasons. However, never leave forms incomplete or unused without explanation
Circle the item(s) for which information is not available and indicate the reason
near the appropriate field:
- If an evaluation was not done, write NOT DONE and provide a reason.
- If the information is not available, but the evaluation was done, write NOT
AVAILABLE and provide a reason.
- If an evaluation is not applicable, write N/A.
101
- If a form can only be partially completed, but will be completed when the
information becomes available, write INCOMPLETE and provide an
estimated date of completion (if known).
- If an entire page of the form cannot be completed (e.g., no parts have any
responses), draw a diagonal line through the form and write NOT DONE,
NOT AVAILABLE, or N/A (NOT APPLICABLE), as appropriate.
- The header information must be completed even if no data are recorded on the
form.
102
1.17 Retention of Study Documentation
Per NIH policy, all study records will be retained for 3 years following study
completion.
After 3 years (July 1, 2020 unless a no-cost extension is granted), all participant
forms containing personal identifiers will be destroyed. Additionally, the key which
links study ID numbers to personal identifiers will be destroyed at this time.
De-identified study data (i.e. any data linked only to a study ID number, after the
key has been destroyed) will be retained indefinitely.
103
1.18 Data Management
This section describes the data management approach that will be used to support the
study and details on how data are to be collected, entered, edited, and corrected.
• Data Types: This study will gather data utilizing standardized assessments,
study-specific forms, data extraction from medical records, and audiotaped
interviews/focus groups.
• Data Entry: Data will be entered from paper-and-pencil forms into the RedCap
database on an ongoing basis by study recruiters (Background Questionnaire) and
data collectors (all survey forms). Data should be entered into RedCap within two
business days of returning to the study office.
• Data Sources for this study include paper-and-pencil forms completed by project
personnel, as well as audiotaped and transcribed interview/focus group data.
• Data Storage: All data gathered using paper-and-pencil study forms will be
entered into the RedCap database. All data gathered via interview/focus groups
will be entered into an NVivo project. Hard copies of paper-and-pencil study
forms will be stored in the PI’s office (if containing identifiers) or in the CHP-101
office suite filing cabinet (if coded by study ID). The original audio recordings of
interviews and focus groups will be destroyed following transcription and upload
to NVivo.
• Data Backup: Data stored on RedCap will be downloaded in CSV format in
weekly intervals, with identifiers removed. Data will be stored on the secure
Division server under S:/Research and Grants/Pyatak/Diabetes Research/REAL
Study/REAL – RESEARCH/Data backups folder.Investigators should involve
104
staff or colleagues with data management experience to assist with the
determination of the data flow, error identification and resolution, development of
useful reports, and deriving a frozen, analytic database from edited or "clean"
records. These areas should be discussed in this section.
• Data Export: Upon completion of baseline testing, and again after completing
follow-up testing, a dataset will be exported from RedCap in CSV format and
“frozen” as the final dataset for that time point.
1.18.1 External Data
In the current study, virtually all data will be collected “in the field,” or outside of the
study office. Therefore, the safe return and storage of data in the study office is
critically important to the success of the study. Individuals who will generate data in
the field include recruiters and data collectors.
Data generated in the field should be returned to the study office as soon as possible,
and no later than the next business day. During the time period when data is outside
the office, it should be protected in a secure location, such as a locked car. However,
the A1C assay machine, and any extra A1C cartridges, should not be stored in a
location where it is exposed to extreme temperatures. Therefore, while outside the
study office, it should be kept in a secure location in the data collector’s home or
other environment with moderate temperatures.
105
1.19 Quality Control Procedures
Data integrity and study credibility depend on factors such as ensuring adherence to
the protocol, obtaining complete follow-up information on all participants enrolled,
and using quality control measures to establish and maintain high standards for data
quality.
1.19.1 Data and Form Checks
The PI or project coordinator will review the RedCap database weekly to ensure data
accuracy and completeness, as well as protocol compliance. These weekly checks
will assess the database for:
Missing data or forms
Out-of-range or erroneous data
Inconsistent and illogical over-time dates
Fields on a "completed form" actually not completed; or no reason for missing
data is provided.
The RedCap database also has quality checks built into the data entry fields; for
example, required data fields are flagged, and data ranges are specified to reduce data
entry errors.
After completing baseline data collection and again after completing follow-up data
collection, 20% of study forms will randomly be selected for data verification by a
graduate research assistant.
1.19.2 Reports
The project manager and/or biostatistician will prepare a monthly report summarizing
the number of forms completed, entered, missing, or with erroneous data.
106
The project manager and/or biostatistician will produce the following reports
biannually in advance of each DSMC meetings:
Study enrollment status (number of participants screened, randomized,
withdrawn, completed per month)
Participant demographics (among all randomized participants: include age,
gender, race, ethnicity, type 1 or type 2 diabetes, and baseline A1C)
Participant status (participant ID, condition assignment, data enrolled, date
completed (or projected to complete), current status, reason for withdrawal, %
intervention adherence, intervention duration)
Adverse events (participant ID, date of onset and end; type of AE, severity,
serious or not, related or not, action taken, and outcome)
1.19.3 Problem Correction Procedures
Strategies for problem correction will depend on the nature of the data quality
problems encountered. Problem correction procedures will be determined by the PI in
consultation with the mentoring team, biostatistician and project manager.
Potential strategies for problem correction include refresher training for data
collectors on correct procedures for completing study forms and RedCap data entry;
contacting participants to obtain missing data; utilizing double data entry procedures
to ensure accuracy; or terminating data collectors who are unable to adhere to the
study protocol.
107
1.20 Data and Safety Monitoring Activities
The Data and Safety Monitoring Committee will meet twice annually to review
participant safety and study quality. Meetings will be convened in person with
conference call technology available for members unable to attend in person.
Data Safety Monitoring Committee members shall include:
Biostatistician
Physician
Vulnerable/minority population expert
Consumer with diabetes
If any of the DSMC members must resign during the course of conducting the
study, the PI will consult with the mentoring team to identify a replacement
member. This person shall be appointed at least one month prior to the next
scheduled meeting of the DSMC.
Safety monitoring activities by the DSMC include:
- Reviewing the protocol with emphasis on data integrity and participant safety
issues
- Monitoring adverse events
- Protecting the confidentiality of the data
- Making recommendations to the PI regarding the study and its progress
DSMC procedures will follow the protocol outlined in the Data and Safety
Monitoring Plan (available on the S: drive in REAL STUDY/REAL –
ADMINISTRATION/DSMC).
108
1.21 Study Completion and Closeout Procedures
After the study is completed, the PI or designee (e.g. project manager, research
assistant) will carry out the following closeout procedures:
Verify that all study procedures have been completed, data have been collected,
and study intervention(s) and supplies are returned to the responsible party or
prepared for destruction.
Assure that all data queries have been completed.
Store all correspondence and study files for future use and/or external audits.
Notify the IRB of the study’s completion and store a copy of the notification.
Send study results to participants who requested notification in the participant exit
survey.
Prepare final report summarizing the study’s conduct.
Prepare final progress report for NIDDK.
Update trial status at ClinicalTrials.gov.
1.21.1 Participant Notification
Participants will complete an exit survey at (A) their final data collection (at a post-
intervention interview or focus group) or (B) by mail, if they are unable or refuse to
complete final data collection. Participants who are mailed the letter may receive up
to four reminder calls to complete the letter. If desired, participants may also
complete the survey by phone.
The survey notifies participants that the study is completed, asks whether they would
like to be informed of the results, and thanks them for their participation. If
109
participants respond to the survey by mail, it should include a self-addressed stamped
envelope to allow participants to return the survey.
Participants who do not consent to future contact by the REAL Diabetes Study in the
exit survey will have their personal identifiers and contact information destroyed
within 4 weeks of disseminating the survey/letter.
110
1.22 Policies
1.22.1 Confidentiality Policies
Investigators and staff members are responsible for maintaining the safety and
confidentiality of participant data. Do not, under any circumstances, release data
to any unauthorized individuals, unless such a release is approved by the study
leadership and NIDDK and is not in violation of applicable Federal and state
laws. The participant confidentiality safeguards adopted in the REAL Diabetes Study
are as follows:
Participant identifiers:
o Identifiers will be linked to study ID numbers on a single log maintained
by the study’s biostatistician.
o Hard copies of participants’ Informed Consent and HIPAA releases will
be stored in a locked filing cabinet in the PI’s office.
o The therapist log, maintained on RedCap, will contain participant contact
information and identifiers. This log will be accessible only to the treating
therapists, research assistants conducting intervention tracking and fidelity
monitoring, and the PI. RedCap restrictions will be in place to prevent
unauthorized access by other personnel.
Data Storage (Hard Copy):
o Hard copies of participant assessments (with Study ID only) will be stored
in a locked filing cabinet in the RA’s office space. Assessment packets
must be returned to the office within 2 business days of completing an in-
home assessment.
111
Data Storage (Electronic):
o All electronic data MUST be stored in the main study folder located at
S:/Research & Grants/Pyatak/Diabetes Research/REAL STUDY.
o Electronic data may NOT be saved to personal computers, cloud-based
storage (e.g. Google Docs, Dropbox), or USB thumb drives.
o RedCap may be viewed from any computer; however, data may not be
downloaded from RedCap and saved to a local computer. Be sure to log
off RedCap after every use.
Access, distribution, and disposal of data:
o No one outside the research team, who lacks appropriate HIPAA and CITI
certifications and is listed on the REAL Diabetes Study’s IRB, may have
access to data which includes personal identifiers.
o Participant records may not be shared with persons outside the study
without the express written consent of the participant.
o Participant identifiers will be destroyed 4 weeks after participant
notification of study closure has been sent, with the exception of
participants who “opt-in” to further contact from the study team.
1.22.2 Publication Policy
The REAL Diabetes Study’s main outcomes paper (including the intention-to-
treat analysis of A1C and diabetes self-care outcomes) will be developed and
submitted for publication within 6 months of final data collection (excluding post-
intervention interviews/focus groups).
112
Basic study results will be submitted to ClinicalTrials.gov within 12 months of
study completion.
For all other publications/analyses stemming from the REAL Diabetes Study, the
following publication policies will hold:
1. All individuals (including study team members, outside researchers, and
students) who wish to publish articles or other products (e.g., conference
presentations, book chapters) in connection with the study must receive
prior approval from the study’s publication committee. The publication
committee consists of Drs. Pyatak, Peters, Whittemore and Spruijt-Metz.
2. To acquire publication committee approval, a paper proposal must be
submitted to all members of the publication committee. The proposal must
include the following information:
a. Primary and secondary author(s)
b. Responsibilities of each author/co-author
c. Working title
d. Timeline/date of submission
e. Hypotheses or research questions
f. Specific data and variables to be analyzed
g. Proposed analytic plan
h. Resources requested (e.g., literature searches, copyediting)
i. Targeted journal
3. To submit an application, please construct an email that provides the
required information under each of the sections listed above and send it to
113
each publication committee member. The committee will respond to each
request within a two week span.
4. Prior to a given paper/product being sent for publication, the publication
committee will review it and offer final suggestions for any changes or
enhancements. If a paper or product is deemed by the committee to be
non-publishable in its content or form, it will be necessary for the
author(s) to conduct a set of stipulated revisions before sending it for
publication. In cases where significant revisions are necessary, the PI
and/or publication committee will renegotiate the paper’s authorship with
the primary author if the pattern of contributors changes from what was
originally specified in the paper proposal.
5. In general, individuals are encouraged to take a lead role on one
paper/product at any given time and work to completion before moving on
to the next paper. However, in addition to being the primary contributor
on a paper, an individual may simultaneously participate as a secondary
contributor on other papers.
6. The REAL Diabetes research team (along with any other meaningful
contributors) will be included as co-authors on any journal articles that
directly relate to the original grant proposal (e.g., the intent-to-treat
analysis, the test of the mediating model). For papers not specified in the
original grant (e.g., mining data for instrument development purposes,
qualitative analyses of the therapists’ logs) the research team members
will not automatically be included as co-authors. In each case, the
114
publication committee will make the determination as to whether a given
product “directly relates” to the original grant proposal.
7. The PI reserves the right to override any decision of the publication
committee. However, it is expected that such an outcome will occur only
under exceptional circumstances.
115
1.23 MOP Maintenance
The MOP serves as a history of the project, documenting the time and nature of
any changes in procedures and policies.
The MOP will be maintained by the project manager (Jeanine Blanchard) with
support from research assistants as needed.
Each page of the MOP should be numbered and dated, and contain a version
number to facilitate any changes and/or additions.
A hard copy of the current MOP should be maintained in the study office. Minor
updates to the MOP may be written into the hard copy; a new version should be
printed for major updates.
Updates should be made on an ongoing basis, with changes tracked in the MOP
Modification Log in Appendix B. The version number should be updated by
tenths for minor revisions (e.g. version 1.0, 1.1, 1.2 etc.) and to a new version
number (e.g. version 1.0, 2.0. 3.0) for major revisions.
The PI will review the MOP on a quarterly basis to ensure that the operating
procedures described are accurate.
116
Appendix A. Protocol Deviation Log
Table 3.5. Protocol Deviation Log
Protocol
Deviation
Code:
Participant
ID#
Date
Deviation
Occurred:
Date Entered
in Protocol
Deviation Log:
Date PI
Notified:
Other Information
PROTOCOL DEVIATION CODES
Consent Form:
1. Missing or not obtained
2. Not signed and dated by participant
3. Does not contain all required signatures
4. Outdated, current IRB-approved version not used
5. Other, please specify in “Other Information”
Randomization:
6. Ineligible participant enrolled and/or randomized
7. Participant randomized prior to determining eligibility for study
117
8. Randomization occurs outside protocol window (e.g. duration of time after
enrollment/baseline testing)
9. Other, please specify in “Other Information”
IRB:
10. Not reporting a serious adverse event within 24 hours
11. IRB approval expired or not kept up to date
12. Enrollment and/or treatment occurs prior to IRB approval or after IRB expiration date
13. Reportable serious adverse events not reported to IRB
14. Other, please specify in “Other Information”
Participant:
15. Receives wrong treatment
16. Intervention visit occurs outside expected follow-up window
17. Data collection visit occurs outside expected follow-up window
18. Unable to contact for >60 days
19. Other, please specify in “Other Information”
Study Data and/or Forms:
20. Incomplete study-initiated data and/or forms
21. Missing study-initiated data and/or forms
22. Incomplete external data (medical record requests, etc.)
23. Missing external data (medical record requests, etc.)
24. Other, please specify in “Other Information”
118
Appendix B. MOP Modification Log
Table 3.6. MOP MODIFICATION LOG
Section
#
Version
#
Date
Modified
Page #
Text
Location
Brief Summary of Modification
119
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Pyatak, Elizabeth A.
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Core Title
Developing and implementing a randomized pilot study of an occupation-based diabetes management intervention
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Keck School of Medicine
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Master of Science
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Clinical and Biomedical Investigations
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09/15/2017
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09/15/2015
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