ENGAGE Pilot Study: Promoting Participation and Health After Stroke
Phase: NA
Conditions: Stroke
Sponsor: University of Pittsburgh

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Study Title:
ENGAGE Pilot Study: Promoting Participation and Health in People with Stroke-Related Disability
A multi-site, single-arm pilot study examining the feasibility, acceptability, and  
estimated effects of a self-management intervention with individualized application 
clinicaltrials.gov Identification Number:
NCT04019275 
Document Date:
May 28, 2020
Lead Principal Investigator: 
Elizabeth R. Skidmore, PhD, OTR/L, Professor, Occupational Therapy, University of Pittsburgh 
Co-Principal Investigators:  
M. Carolyn Baum, PhD, OTR/L, Professor, Occupational Therapy, Washington University Joy 
Hammel, PhD, OTR/L, Occupational Therapy, University of Illinois at Chicago
Supported by: 
Clinical Translational Science Award SPIRIT Program (UL1 TR001857; UL1 TR002345) 
Institutional Review Board of Record: 
University of Pittsburgh, PRO19030256 

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Tool Revision History 
Version Number: 1.0 
Version Date: May 21, 2019 
Summary of Revisions Made: Creation of the initial protocol 
Version Number: 2.0 
Version Date: May 28, 2020 
Summary of Revisions Made: Updated intervention procedures; modification for remote 
delivery; 
Version Number: 
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Summary of Revisions Made:  
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TABLE OF CONTENTS 
Page 
ENGAGE PILOT STUDY MULTI-SITE PROTOCOL .......................................................... 1 
Tool Revision History ................................................................................................................. 2 
TABLE OF CONTENTS ............................................................................................................. 3 
STUDY TEAM ROSTER........................................................................................................... 5 
PRÉCIS ....................................................................................................................................... 7 
1. STUDY OBJECTIVES ............................................................................................................. 7 
1.1 
Primary Objective ........................................................................................................... 7 
1.2 
Secondary Objectives...................................................................................................... 7 
2. BACKGROUND AND RATIONALE .................................................................................... 8 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 8 
2.2 
Study Rationale ............................................................................................................... 8 
3. STUDY DESIGN ....................................................................................................................... 9 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 10 
4.1 
Inclusion Criteria .......................................................................................................... 10 
4.2 
Exclusion Criteria ......................................................................................................... 10 
4.3 
Study Enrollment Procedures ....................................................................................... 10 
5. STUDY INTERVENTIONS .................................................................................................. 10 
5.1 
Interventions, Administration, and Duration ................................................................ 10 
5.2 
Handling of Study Interventions ................................................................................... 11 
5.3 
Concomitant Interventions ............................................................................................ 11 
5.3.1 Allowed Interventions ............................................................................................... 11 
5.3.2 Required Interventions .............................................................................................. 11 
5.3.3 Prohibited Interventions ............................................................................................ 11 
5.4 
Adherence Assessment ................................................................................................. 11 
6. STUDY PROCEDURES ........................................................................................................ 12 
6.1 
Schedule of Evaluations ................................................................................................ 12 
6.2 
Description of Evaluations ............................................................................................ 13 
6.2.1 Screening Assessment ............................................................................................... 13 
6.2.2 Pre-Intervention Assessment .................................................................................... 13 

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6.2.3 Blinding..................................................................................................................... 15 
6.2.4 Post-Intervention Assessment ................................................................................... 15 
7. SAFETY ASSESSMENTS ..................................................................................................... 15 
7.1 
Specification of Safety Parameters ............................................................................... 15 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters
Error! Bookmark not defined. 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 15 
7.4 
Reporting Procedures .................................................................................................... 15 
7.5 
Followup for Adverse Events ....................................................................................... 15 
7.6 
Safety Monitoring ......................................................................................................... 15 
8. INTERVENTION DISCONTINUATION ........................................................................... 15 
9. STATISTICAL CONSIDERATIONS .................................................................................. 16 
9.1 
General Design Issues ................................................................................................... 16 
9.2 
Sample Size and Randomization .................................................................................. 16 
9.3 
Definition of Populations .............................................................................................. 16 
9.4 
Interim Analyses and Stopping Rules ........................................................................... 16 
9.5 
Outcomes ...................................................................................................................... 16 
9.5.1 Primary Outcome ...................................................................................................... 16 
9.5.2 Secondary Outcomes ................................................................................................ 16 
9.6 
Data Analyses ............................................................................................................... 16 
10. DATA COLLECTION AND QUALITY ASSURANCE .................................................. 17 
10.1 
Data Collection Forms .................................................................................................. 17 
10.2 
Data Management ......................................................................................................... 17 
10.3 
Quality Assurance ......................................................................................................... 17 
10.3.1 
Training ................................................................................................................. 17 
10.3.2 
Protocol Deviations ............................................................................................... 17 
10.3.3 
Monitoring ............................................................................................................ 17 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................... 17 
11.1 
Institutional Review Board (IRB) Review .................................................................... 17 
11.2 
Informed Consent Forms .............................................................................................. 18 
11.3 
Participant Confidentiality ............................................................................................ 18 
11.4 
Study Discontinuation ................................................................................................... 18 
12. COMMITTEES..................................................................................................................... 18

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STUDY TEAM ROSTER 
Executive Committee Members 
Elizabeth Skidmore, Lead Principal Investigator, University of Pittsburgh 
Department of Occupational Therapy, Bridgeside Point 1, 100 Technology Drive, 
Suite 350, Pittsburgh, PA, 15219, (412) 383-6617, skidmore@pitt.edu  
Carolyn Baum, Co-Principal Investigator, Washington University 
Department of Occupational Therapy, 4444 Forest Park Avenue, CB 8505, 
St. Louis, MO, 63108 (314) 286-1618, baumc@wustl.edu  
Joy Hammel, Co-Principal Investigator, University of Illinois at Chicago 
Department of Occupational Therapy, 1919 W. Taylor Street, 334 AHSB, 
Chicago, IL, 60612 (312) 996-3513, hammel@uic.edu  
University of Pittsburgh Team Members 
Rachelle Brick, Co-Investigator, University of Pittsburgh 
Department of Occupational Therapy, Bridgeside Point 1, 100 Technology Drive, 
Suite 350, Pittsburgh, PA, 15219, (412) 383-6617, rsb50@pitt.edu  
Jessica Kersey, Co-Investigator, University of Pittsburgh 
Department of Occupational Therapy, Bridgeside Point 1, 100 Technology Drive, 
Suite 350, Pittsburgh, PA, 15219, (412) 383-6617, jmk286@pitt.edu  
Kelsey Voltz, Co-Investigator, University of Pittsburgh 
Department of Occupational Therapy, Bridgeside Point 1, 100 Technology Drive, 
Suite 350, Pittsburgh, PA, 15219, (412) 383-6617, klv28@pitt.edu  
Laura Waterstram, Research Laboratory Manager, University of Pittsburgh 
Department of Occupational Therapy, Bridgeside Point 1, 100 Technology Drive, 
Suite 350, Pittsburgh, PA, 15219, (412) 383-1055, lfw11@pitt.edu  
Washington University Team Members 
Anna J. Neff, Co-Investigator, Washington University 
Department of Occupational Therapy, 4444 Forest Park Avenue, CB 8505, 
St. Louis, MO, 63108 (314) 286-1618, ajneff@wustl.edu  
Michelle Klein, Co-Investigator, Washington University 
Department of Occupational Therapy, 4444 Forest Park Avenue, CB 8505, 
St. Louis, MO, 63108 (314) 286-1618, mklein23@wustl.edu  
University of Illinois at Chicago Team Members 
Heidi Fisher, Co-Investigator, University of Illinois at Chicago 
Department of Occupational Therapy, 1919 W. Taylor Street, 334 AHSB, 
Chicago, IL, 60612 (312) 996-3513, hwaldi1@uic.edu  
Maureen Gecht, Co-Investigator, University of Illinois at Chicago 
Department of Occupational Therapy, 1919 W. Taylor Street, 334 AHSB, 
Chicago, IL, 60612 (312) 996-3513, mgecht@uic.edu  
Emily Kringle, Co-Investigator, University of Illinois at Chicago 
Department of Occupational Therapy, 1919 W. Taylor Street, 334 AHSB, 
Chicago, IL, 60612 (312) 996-3513, kringle@uic.edu  

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University of Pittsburgh Peer Mentor 
Tina Harris, Pittsburgh, PA  
Washington University Peer Mentors 
Solar Gordon, St. Louis, MO  

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PRÉCIS 
Study Title 
ENGAGE: Promoting Participation and Health in People with Stroke-Related 
Disability 
Objectives 
The objectives of this study are to examine the feasibility, acceptability, and safety of 
a multi-site implementation of ENGAGE and to describe change in community 
participation among adults with stroke-related disability and low income.  
Design and Outcomes  
This is a multi-site, multi-phase (in-person, remote), single-arm community-based 
pilot study examining the feasibility, acceptability, safety, and estimated effects of 
ENGAGE. Indices of intervention feasibility, acceptability, and safety will be 
assessed. Community participation and measures of physical, social and emotional 
health will be administered before and after the intervention. 
Interventions and Duration 
All participants will receive a 6-week (12 sessions, 2 times per week) self-
management intervention with social learning (group training) and guided skill 
development (individual application).  
Sample Size and Population 
Participant will have mild to moderate stroke-related disability for a minimum of 3 
months and identified limitations in community participation.  
1. STUDY OBJECTIVES
1.1 
Primary Objective
The primary objective of this study is to examine the feasibility, acceptability, and 
safety of a multi-site, multi-phase implementation of ENGAGE to address 
community participation among adults with stroke-related disability and low income. 
We will partner with Washington University Community Research Fellows and the 
University of Pittsburgh Community PARTners to adapt and implement the 
intervention to address the needs of people with mild to moderate stroke-related 
disability and low income who live in Pittsburgh, St. Louis, and Chicago. We will 
clarify and describe the specific adaptations necessary to support this population. We 
will test this intervention through in-person and remote delivery methods. Feasibility 
will be indicated by >90% of target enrollment, >90% retention, and >90% 
intervention fidelity at each site; acceptability will be indicated by >90% participant 
satisfaction at each site; and safety will be indicated by <3% participants with a 
reportable event (i.e., injurious fall) at each site. 
1.2 
Secondary Objectives 
The secondary objective of this study is to describe intervention response among 

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participants at each site, indicated by pre-post change in PROMIS Ability to 
Participate in Social Roles and Activities. We will also explore changes in 
satisfaction with participation (PROMIS Satisfaction with Participation in Social 
Roles and Activities), physical activity (step count/day), sedentary behavior (sitting 
time/day), social (PROMIS Social Isolation), and perceived health (PROMIS-29) to 
inform future studies. 
2. BACKGROUND AND RATIONALE
2.1 
Background on Condition, Disease, or Other Primary Study Focus
Significant advancements in acute medical management have shifted stroke from an 
acute condition with a high prevalence of mortality to a chronic condition with high 
prevalence of morbidity. One of the leading causes of chronic illness and disability 
worldwide, stroke results in residual impairments in sensorimotor, cognition, and 
communication impairments. These impairments reduce over time, but few people 
have complete restoration of function. Hence, people with stroke-related disability do 
not resume pre-stroke levels of community participation (education; paid or volunteer 
work; civic, social, and religious activities; and leisure). Low levels of community 
participation are associated with inactivity, sedentary behavior, and social isolation, 
each contributors to cardiovascular disease, diabetes, obesity, pulmonary conditions, 
depression – and secondary stroke. These consequences are particularly problematic 
for people with low income who have limited resources. 
It may be possible to improve community participation after stroke, despite residual 
disability. Unfortunately, interventions remain under-developed and under-studied. 
Thus, the NIH Research Plan on Rehabilitation identifies this as one of the critical 
focus areas for rehabilitation research. We need community-focused and individually-
tailored, and culturally-responsive interventions to promote community participation, 
particularly in portions of the population most vulnerable to poor health outcomes. 
2.2 
Study Rationale 
Our team of occupational therapy scientists has designed ENGAGE, a self-
management training program that uses social learning and guided discovery to help 
people with mild to moderate stroke-related disability resume community 
participation, and to develop a strong network of social support. Our previous 
research demonstrates that self-management training with social learning results in 
significantly greater gains in self-efficacy for community participation, as well as 
improved “enfranchisement” (a sense of belonging) compared to a wait-list control 
group. That is, participants felt more confident and more integrated and valued in the 
community after the intervention (Cohen’s d=1.45). Additional research demonstrates 
that guided skill development helps people with stroke-related cognitive impairments 
1) identify and solve problems in everyday activities, and 2) achieve greater
improvements in independence (Cohen’s d=1.06) and executive functions (Cohen’s
d=1.38) compared to usual rehabilitation practices. Guided skill development teaches
people how to identify problematic daily activities and barriers, and generate and
evaluate their own strategies to address barriers. Instructors facilitate learning through

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prompts and questions, rather than directly instructing participants. We posit that self-
management training with social learning and guided skill development may 
comprise the optimal program to promote improved frequency and satisfaction with 
community participation, and subsequently improve overall health. 
However, the combination of these elements has yet to be studied in people with 
chronic stroke-related disability who live with low income – one of the most 
vulnerable segments of the population. By partnering with the Community Research 
Fellows Program at Washington University and the Community PARTners Program 
at the University of Pittsburgh, this multisite team seeks to design and implement a 
culturally-responsive program to promote community participation among people 
with stroke-related disability and low income. This new collaboration is the next 
logical step in the development and examination of community-based interventions to 
promote self-management and community participation after stroke.  
The self-management training will be administered by an occupational therapist and a 
peer-mentor in group sessions (social learning). Individual application of the self-
management training content will be facilitated with guided skill development 
principles. The intervention will be 12 two-hour sessions, offered 2 times per week 
for 6 weeks, based on previous intervention dosing studies. There are limited known 
and potential risks because the intervention focuses on doing routine daily activities 
in the home and the community, as would normally be encountered in the course of 
everyday life. However, there is a minimal risk of frustration fatigue, fall, or injury 
that may result from increasing physical and social activity levels over the course of 
time. These risks will be minimized through supervision of licensed occupational 
therapists. 
ADDENDUM: With the onset of the pandemic, we developed methods to deliver this 
intervention program remotely. People with stroke-related disability, particularly 
those in low income communities, face unique problems in the home and the 
community during pandemic conditions. We decided to add a second phase of the 
study, delivering the intervention remotely, to address these needs, and to compare 
metrics across phases (in person, remote).  
3. STUDY DESIGN
This is a multi-site, multi-phase single-arm community-based clinical trial examining 
the feasibility, acceptability, safety, and variation in changes in community 
participation attributed to ENGAGE among community-dwelling adults with mild to 
moderate stroke-related disability and low income. The 6 week intervention (12 two-
hour sessions, 2 times per week) intervention will be delivered in community-based 
settings (in person) or in the home (remote), and assessments will be delivered in the 
home or community-based settings (in person) or via teleconference (remote). 
Assessments will be administered by independent evaluators at each site, and all data 
will be collected electronically and stored in REDCap, a cloud-based data 
management system accessible to all investigators at all sites. 

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4. SELECTION AND ENROLLMENT OF PARTICIPANTS
4.1 
Inclusion Criteria
Inclusion criteria are: 1) ages 18 and older, 2) chronic stroke (minimum 3 months), 3) 
community-dwelling, 4) mild to moderate stroke-related disability (NIHSS ≥ 16), 5) 
restrictions in community participation (Activity Card Sort indicates retention of 
<80% of pre-stroke community participation activities), 6) low income (uninsured or 
underinsured), and 7) able to provide written informed consent. 
4.2 
Exclusion Criteria 
Exclusion criteria are: 1) currently receiving rehabilitation services, 2) dementia 
diagnosis, 3) severe aphasia (0 or 1 on the Boston Diagnostic Aphasia Examination 
Severity Rating Scale), 4) current major depressive, bipolar, or psychotic disorder 
(PRIME-MD), or 5) substance abuse within 3 months (Mini-International 
Neuropsychiatric Interview).  
4.3 Study Enrollment Procedures 
We will recruit research participants from stroke and rehabilitation research registries 
and stroke recovery support groups. Interested participants will be encouraged to 
contact the study team by telephone or email, and the study team will follow up with 
an initial phone call using the approved recruitment script. If the potential participant 
provides verbal consent as per approved procedures, the study team will  describe the 
purpose of the study, the procedures involved and the potential risks and benefits of 
study participation. Persons providing written or electronic informed consent will be 
asked to describe the study in their own words to ensure their understanding. In 
addition, persons providing informed consent will be invited to ask questions about 
the research study and will be provided time to think about study participation, prior 
to providing informed consent. Even after informed consent is obtained, participants 
will be invited to ask questions about the study and ongoing participation. All of these 
procedures will be documented in the research record via tablet and uploaded to 
REDCap, the cloud-based data management system. 
All contacts with potential research participants will be documented in the screening 
log maintained in REDCap. Potential participants who do not provide informed 
consent or are ineligible will be identified by a code (NC1, NC2) and the reason for 
non-participation or ineligibility will be maintained. No identifiers will be maintained 
or linked to these codes. Participants who do provide informed consent will be 
identified by their assigned study identification code (with a linking file maintained 
separately). Study identification codes will be assigned through REDCap. 
5. STUDY INTERVENTIONS
5.1 
Interventions, Administration, and Duration
The intervention, ENGAGE, will be delivered by trained occupational therapists and 
peer mentors. Therapists and mentors will deliver the 12 intervention sessions (2 
sessions per week for 6 weeks) to groups of 6 to 8 participants, at a university-owned 

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or community center (in person) or via teleconference with provided technology and 
internet access (remote). Each session will be 2 hours and will be video recorded.  
The intervention blends self-management training with social learning and guided 
skill development to promote community participation after stroke-related disability. 
For this project, ENGAGE will be tailored to the needs of people with low income 
who may have few resources or supports.  
Self-management training sessions comprise 12 topics (building community 
participation plans, understanding the stroke experience, engaging in the community, 
advocating for self and others, using social networks, strategies for participation, 
staying active and well, civic and volunteer activities, applying what we learned, 
sharing what we learned). During each of these sessions, therapists and mentors will 
use social learning and guided skill development principles to aid participants in 
identifying individual and collective goals, addressing these goals, and debriefing to 
support application. Participants will use the Activity Card Sort (published 
standardized tool with photos of activities in the home and community, sorted by 
importance to the participant) and workbooks to guide these activities during and 
between sessions. Refer to the intervention manual for specific procedures. 
5.2 
Handling of Study Interventions 
Prior to recruitment, the investigators will meet with community members and peer 
mentors to discuss adaptations to the intervention protocol, language, and materials to 
optimize the delivery of the intervention for this study population. Also prior to 
recruitment, the occupational therapists and peer-mentors at each site will undergo 
training in intervention principles and standardized procedures. All intervention 
procedures will be documented using standardized forms available via tablet, and 
uploaded to REDCap. During the study, the occupational therapists and peer mentors 
will participate in weekly calls to discuss the implementation of the intervention and 
assess the need for adaptation. Refer to the intervention manual for specific 
procedures. 
5.3 
Concomitant Interventions 
5.3.1 Allowed Interventions 
All concurrent treatments and services will be permitted, with the exception of 
concurrent rehabilitation services. 
5.3.2 Required Interventions 
No interventions beyond ENGAGE are required. 
5.3.3 Prohibited Interventions 
People receiving concurrent occupational, physical, and speech language pathology 
rehabilitation services will be excluded from the study.  
5.4 
Adherence Assessment 
Participant adherence will be indicated through attendance at ENGAGE sessions 

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(90%, 10 of 12 sessions). This will serve as one measure of feasibility. Therapist and 
peer-mentor adherence, or fidelity to standardized intervention principles, will be 
assessed using a fidelity checklist in combination with video recordings and session 
documentation. Refer to the intervention manual for specific procedures. 
6. STUDY PROCEDURES
6.1 
Schedule of Evaluations
Assessment 
Screening: 
(Day 
-14 to -1)
Pre-
Intervention 
(Day -14 to -1) 
Intervention 
Sessions 
(Day 0 to 42) 
Post-
Intervention 
(Day 43 to 57) 
Referral Log 
Informed Consent 
Screening Assessments 
X 
Screening Checklist 
X 
Participant Characteristics 
X 
Comorbidity Questionnaire 
X 
Cognitive Assessment 
X 
Social Support Survey 
X 
Ability to Participate 
X 
Satisfaction with Participation 
X 
X 
Social Isolation 
X 
X 
Global Health 
X 
X 
Community Participation 
X 
X 
Participation Activation 
X 
X 
Participation Self-Efficacy 
X 
X 
Patient Activation 
X 
X 
Chronic Disease Self-Efficacy 
X 
X 
Sedentary Behavior 
X 
X 
Physical Activity Scale 
X 
X 
ActivPal 
X 
X 
Intervention Record 
X 

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6.2 
Description of Evaluations 
6.2.1 Screening Assessment 
The screening assessment will be administered by trained evaluators and will take 1 
hour. 
•
The National Institutes of Health Stroke Scale is a valid and reliable scale to
assess neurological impairment associated with stroke. Items test alertness,
orientation, command following, eye and limb movements, vision, language and
sensory perception.
•
The Activity Card Sort is a valid and reliable assessment of community
participation.
•
The Boston Diagnostic Aphasia Examination severity scale assesses aphasia
impairment severity in three domains: comprehension, expression, and fluency.
•
The PRIME-MD with Mini-Neuropsychiatric Interview module assesses presence
of mood disorders.
N. B. As part of the assessment of mood, we are including items to address risk of 
suicidality, a potential risk associated with depression. This action was advised by a 
physician co-investigator and geriatric neuropsychiatrist Ellen Whyte, who advises all 
assessments of depression including these items. If in the course of assessment it is 
determined that an individual has either major depressive disorder or suicidality, we 
will 1) refer the participant to local services (in Pittsburgh, the RESOLVE Crisis 
Network, a 24 hour service that directs individuals with major depressive disorder 
and/or suidicality to immediate care), 2) notify the contact person identified by the 
participant, and 3) notify the treating physician on service at the time of referral. We 
will document these actions in the study records. This 3-step plan has been effective 
when we encountered major depressive disorder in our previous studies with this 
population (over the last 10 years).  
6.2.2 Pre-Intervention Assessment 
The pre-intervention assessment will be administered by trained evaluators and will 
take 1.5 hours.  
•
The Participant Characteristics Form will record age, sex, race, ethnicity,
education, vocational status, residential status, social support, stroke
characteristics, and stroke chronicity.
•
The Self-Administered Comorbidity Questionnaire is a participant-reported
measure of comorbidities. Participants are asked to report on the presence or
absence of specific chronic diseases, if they receive treatment for the disease, and
if the disease interferes with their daily life activities.
•
The Montreal Cognitive Assessment is brief, standardized measure of cognitive
function. Participation are asked to complete a series of cognitive tasks assessing
attention, memory, visuospatial function, and selected executive function
domains, and their performance is scored by a trained assessor.
•
The Medical Outcomes Survey Social Support Survey is a brief questionnaire that
assesses companionship, assistance and support from others.

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•
The PROMIS Ability to Participate in Social Roles and Activities 8-item short
form will be the primary measure of community participation. The measure
assesses difficulty participating in social roles and activities (1=always difficult,
5=never difficult).
•
The PROMIS Satisfaction with Social Roles and Activities 8-item short form will
be used to assess satisfaction with community participation (1=always satisfied,
5never satisfied).
•
The PROMIS Social Isolation 8-item short form will be used to assess perceptions
of social isolation (1=never, 5=always).
•
The PROMIS Global Health 43-item short form will be used to assess perceived
global health (1=excellent health, 5=poor health).
•
The Community Participation Indicators Scale is a detailed questionnaire that
assesses the frequency of community participation activities, satisfaction, and
degree of enfranchisement (belongingness) that individuals with stroke-related
disability have with respect to community participation.
•
The Community Participation Activation Scale is a brief questionnaire that
assesses the active role that people with stroke-related disabilities take in
engaging in community participation.
•
The Participation Self-Efficacy Scale assesses confidence in understanding and
managing one's community participation.
•
The Chronic Disease Self-Efficacy Scale assesses confidence in understanding
and managing one's health condition and associated symptoms.
•
The Patient Activation Scale assesses the active role that people with take in
managing their health and symptoms.
•
The Sedentary Behavior Questionnaire asks participants to report time spent in 9
specific sedentary behaviors during a typical weekday and weekend. This
assessment demonstrates validity and reliability for measuring sedentary behavior
in the adult population.
•
The Physical Activity Scale for Individuals with Physical Disabilities will
measure self-reported physical activity. This questionnaire asks participants to
report time spent in 13 types of physical activity over the past 7 days.
•
ActivPAL(TM) monitors will be used to assess sedentary behavior and step count
over 7 days. The ActivPAL is a small, lightweight monitor that quantifies time
spent in sitting, reclined, standing, and stepping. The participant will be provided
the "ActivPAL Guide" as a reference guide. We will follow a 24-hour wear
protocol in which the participants will wear the device on their thigh for 7 days. A
trained assessor will train the participant on appropriate care and use of the
device. The ActivPAL will be waterproofed and fastened to the individual's thigh
using a non-latex, gentle adhesive (Tegaderm). Prior to adhering the device, the
assessor will conduct a gross sensation tactile localization screen to detect
impairment in sensation on the participant's anterior thigh. The assessor will ask
the participant to close their eyes and will lightly touch the participant's anterior
thigh in the region where the ActivPAL will be positioned (anterior, upper half).
He/she will ask the participant to indicate when and where the researcher touched.
If impaired gross sensation is detected, or the participant reports sensitivity to
adhesives, alternative strategies for positioning the device and alternate wear

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schedules (such as removing the device during non-waking hours or wearing the 
device for fewer than 7 days) will be identified. Participants will also be asked to 
record their bedtime and waking time in the "ActivPAL Diary". Sedentary bouts, 
sedentary breaks, and steps per day will be assessed using the ActivPAL monitor. 
6.2.3 Blinding 
There is no blinding in this single arm study. That said, independent evaluators will 
compete the post-intervention assessments. 
6.2.4 Post-Intervention Assessment 
The post-intervention assessment will be administered by trained independent 
evaluators and will take 1 hour.  
•
PROMIS Ability to Participate in Social Roles and Activities
•
PROMIS Satisfaction with Social Roles and Activities
•
PROMIS Social Isolation
•
PROMIS Global Health
•
Community Participation Indicators Scale.
•
Community Participation Activation Scale
•
Participation Self-Efficacy Scale
•
Chronic Disease Self-Efficacy Scale
•
Patient Activation Scale
•
Sedentary Behavior Questionnaire
•
Physical Activity Scale for Individuals with Physical Disabilities
•
ActivPAL(TM) (7 day wear)
•
Client Satisfaction Questionnaire
7. SAFETY ASSESSMENTS
7.1 
Adverse Events
Given the benign nature of the intervention and assessment procedures, we anticipate 
minimal to no adverse events. Nonetheless we will monitor physical safety of 
participants during the intervention period, to assess the potential for adverse events. 
7.2 
Reporting Procedures 
Any adverse events will be reported to the IRB immediately and documented in the 
regulatory binder. 
7.3 
Safety Monitoring 
The Executive Committee will meet weekly to review participant safety. Any adverse 
events will be reported to the IRB immediately and documented in the regulatory 
binder. 
8. INTERVENTION DISCONTINUATION
There are no foreseeable circumstances that may result in intervention 

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discontinuation, barring unforeseen medical events prohibiting participation (e.g., 
recurrent stroke). 
9. STATISTICAL CONSIDERATIONS
9.1 
General Design Issues
This pilot study is a descriptive study. Data will be plotted visually and characterized 
through descriptive statistics with appropriate indices of variation when indicated. 
9.2 
Sample Size and Randomization 
Given the focus on feasibility and the prematurity of hypothesis testing, we estimated 
the sample needed to assess feasibility of a multi-site implementation of the 
intervention protocol. With a minimum of 20 participants per site we will have a 
sufficient sample to examine feasibility, acceptability, safety, and the range in 
magnitude of change in community participation measures within each site (Cohen’s 
d). With 60 participants, we will have 80% power to detect a moderate effect 
(Cohen’s d=.37) of within-participant change using a two-tailed paired samples t-test 
with α=.05. Our pilot studies’ effect sizes ranged from d=.37 to .97 and our detectable 
effects fall within this range.  
9.3  
Definition of Populations 
All participant data will be analyzed regardless of study completion. 
9.4 
Interim Analyses and Stopping Rules 
Given the pilot phase of this study and the benign nature of the intervention and the 
intended outcome, no interim analyses or stopping rules will be used. 
9.5 
Outcomes 
9.5.1 Primary Outcome   
Feasibility will be indicated by >90% of target enrollment, >90% retention, and 
>90% intervention fidelity at each site; acceptability will be indicated by >90%
participant satisfaction at each site; and safety will be indicated by <3% participants
with a reportable event (i.e., injurious fall) at each site, and by phase.
9.5.2 Secondary Outcomes  
We will also characterize variation in change of community participation within 
subjects within and between sites, within each phase, using change scores, effect sizes 
and confidence intervals. 
9.6 
Data Analyses 
We will conduct descriptive analyses to address the feasibility, acceptability, and 
safety benchmarks in the primary aim. We will examine univariate and bivariate 
distributions of variables, and plot community participation scores to visually 

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characterize changes in community participation within and between sites to address 
the secondary aim. We will also calculate within subjects change in community 
participation as well as Cohen’s d effect sizes of change for both sites combined, and 
each site. 
10. DATA COLLECTION AND QUALITY ASSURANCE
10.1 Data Collection Forms
All data will be collected using electronic data entry (with the exception of the 
participant workbooks used in the interventions). Electronic data will be uploaded 
into a single REDCap site, a cloud-based data management system maintained at the 
University of Pittsburgh, but accessible to all investigators at all sites.  
10.2 Data Management 
Data will be collected using tablets, and uploaded and maintained in REDCap, hosted 
at the University of Pittsburgh.  
10.3 Quality Assurance 
10.3.1 Training 
Intervention staff will be trained by site principal investigators at a two day course 
and monitored through weekly meetings during active periods of intervention. 
Assessment staff will as be trained by site principal investigators and monitored 
through monthly meetings. 
10.3.2 Protocol Deviations 
Protocol deviations will be identified through regularly scheduled audits of study 
files, paper and electronic, as well as through team meetings. These deviations will be 
reported to the IRB immediately, and documented in the regulatory binder. 
10.3.3 Monitoring 
The Executive Committee will meet weekly to review recruitment and retention, data 
collection, issues of confidentiality, and data integrity. The University of Pittsburgh 
research team will assess data integrity through regularly scheduled reviews of 
REDCap.  
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY
11.1 Institutional Review Board (IRB) Review
This protocol and the informed consent document and any subsequent modifications 
will be reviewed and approved by the single IRB process, with the University of 
Pittsburgh serving as the IRB of record.  

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11.2 Informed Consent Forms 
All participants will provide written or electronic informed consent. The consent form 
describes the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation. Participants will be given the opportunity to ask questions 
prior to giving consent, and ongoing consent will be assessed as the study proceeds. 
Participants will be given a copy of the consent form, and this process will be 
documented in the research record. 
11.3 Participant Confidentiality 
All data, records, and video recordings will be identified only by study identification 
code to maintain confidentiality. Paper files will be kept in a locked file cabinet. 
Electronic data will be entered, maintained, and analyzed in a secure manner, 
consistent with approved data security procedures.  
11.4 Study Discontinuation 
The study may be discontinued at any time to ensure that research participants are 
protected.  
12. COMMITTEES
The study will be led by an Executive Committee comprised of the site principal 
investigators who will meet weekly throughout the duration of the study. The 
Executive Committee will oversee the design, implementation, conduct, and reporting 
of study findings.