teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase)
Phase: NA
Conditions: Stroke, Stroke, Ischemic, Stroke Hemorrhagic
Sponsor: University of Minnesota

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 1 of 44 
Template Revised On: 10/28/2022 
PROTOCOL COVER PAGE 
 
Protocol Title 
teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative 
Phase) 
Principal 
Investigator/Faculty 
Advisor 
Name: Emily Kringle 
Affiliation:  ☒UMN   ☐Fairview   ☐ Gillette 
UMN Home Department: Kinesiology 
UMN Home Dept ID: 11222 
Telephone Number: (612) 624-8994 
Email Address: ekringle@umn.edu 
Student Investigator 
Name: N/A 
Current Academic Status (Student, Fellow, Resident): N/A 
  
Department: N/A 
Telephone Number: N/A 
Institutional Email Address: N/A 
Scientific Assessment 
Nationally-based, federal funding organizations 
IND/IDE # (if 
applicable) 
N/A 
IND/IDE Holder 
N/A 
Investigational Drug 
Services # (if 
applicable) 
N/A 
Version 
Number/Date: 
V5.07.21.2023 
 
 
 
 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 2 of 44 
Template Revised On: 10/28/2022 
 
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 
04.17.2023 
Added personnel (Jessica Walsh), 
assessments (blood pressure, sit-to-
stand assessments, technology 
questionnaire) 
Yes 
2 
06.30.2023 
Updated local recruitment methods 
No 
3 
07.10.2023 
Updated study inclusion and 
exclusion criteria 
No 
4 
7.21.2023 
Updated local recruitment methods 
and recruitment materials, removed 
personnel (Casey Dahl) 
No 
 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 3 of 44 
Template Revised On: 10/28/2022 
Table of Contents 
 
1.0 
Objectives .......................................................................................................................... 5 
2.0 
Background ........................................................................................................................ 5 
3.0 
Study Endpoints/Events/Outcomes .................................................................................. 7 
4.0 
Study Intervention(s)/Investigational Agent(s) ................................................................. 7 
5.0 
Procedures Involved .......................................................................................................... 9 
6.0 
Data and Specimen Banking ............................................................................................ 15 
7.0 
Sharing of Results with Participants ................................................................................ 16 
8.0 
Study Population ............................................................................................................. 17 
9.0 
Vulnerable Populations ................................................................................................... 19 
10.0 
Local Number of Participants .......................................................................................... 22 
11.0 
Local Recruitment Methods ............................................................................................ 22 
12.0 
Withdrawal of Participants .............................................................................................. 25 
13.0 
Risks to Participants ........................................................................................................ 26 
14.0 
Potential Benefits to Participants .................................................................................... 28 
15.0 
Statistical Considerations ................................................................................................ 28 
16.0 
Health Information and Privacy Compliance .................................................................. 29 
17.0 
Confidentiality ................................................................................................................. 34 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ............................. 34 
19.0 
Provisions to Protect the Privacy Interests of Participants ............................................. 35 
20.0 
Compensation for Research-Related Injury .................................................................... 36 
21.0 
Consent Process .............................................................................................................. 36 
22.0 
Setting .............................................................................................................................. 38 
23.0 
Multi-Site Research ......................................................................................................... 38 
24.0 
Coordinating Center Research ........................................................................................ 39 
25.0 
Resources Available ......................................................................................................... 39 
26.0 
References ....................................................................................................................... 40 
 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 4 of 44 
Template Revised On: 10/28/2022 
ABBREVIATIONS/DEFINITIONS 
● ABLE/teleABLE: Activating Behavior for Lasting Engagement (name of intervention 
under study) 
● ACS3: Activity Card Sort 
● BIPOC: Black, Indigenous, People of Color 
● CITI: Collaborative Institutional Training Initiative 
● CKRI: Courage Kenny Rehabilitation Institute 
● CTSI: Clinical and Translational Science Institute 
● DoD: Department of Defense 
● DWELL: Disability and WELLness Laboratory 
● HIPAA: Health Information Portability and Accountability Act  
● ICAN: Identify Choose Add/Adapt Notice 
● ID: Identification 
● IRB: Institutional Review Board 
● ISP: Information Security and Privacy 
● LGBTQ: Lesbian Gay Bisexual Transgender Queer 
● M: Mean 
● MoCA: Montreal Cognitive Assessment 
● NIH: National Institutes of Health 
● PI: Principal Investigator 
● REDCap: Research Electronic Data Capture 
● SD: Standard Deviation 
 
 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 5 of 44 
Template Revised On: 10/28/2022 
1.0 
Objectives 
1.1 Purpose: This project is a first step in trial planning for a future pilot randomized 
controlled trial which examines a remotely delivered intervention designed to 
reduce post-stroke sedentary behavior. The purpose of this project is to adapt the 
Activating Behavior for Lasting Engagement (ABLE) intervention protocol for 
remote delivery using videoconferencing, and to optimize trial study procedures 
in preparation for a future pilot randomized controlled trial. Our two goals in the 
present project are: 1) iteratively adapt the ABLE intervention to enable safe 
remote intervention delivery using videoconferencing (teleABLE), and 2) optimize 
acceptability of the teleABLE intervention and assessment procedures. 
The PI has made draft adaptations to the ABLE intervention protocol in 
preparation for adapting ABLE to teleABLE. We will recruit 10 ambulatory, 
community-dwelling people with stroke who sustained their first-ever stroke ≤12 
months prior to study enrollment and have access to a personal device that is 
compatible with videoconferencing (e.g. tablet, smartphone, computer). A 
sequential descriptive case series will be used to iteratively update the 
intervention protocol based on feedback from participants and therapists. 
Participants will complete assessments at 2 timepoints (baseline, 2-months), 
participate in 12 intervention sessions over 6 weeks, and complete 2 interviews. 
Findings from this study will result in a refined intervention and assessment 
protocol that will be deployed in a future randomized controlled trial examining 
the feasibility and effects of the teleABLE intervention. 
Aim 1: Adapt the ABLE intervention protocol to enable safe remote intervention 
delivery using videoconferencing. 
Hypothesis 1a: People with stroke and therapists will identify training content and 
intervention delivery strategies that support engagement in the teleABLE 
intervention (intervention interview, therapist documentation). 
Hypothesis 1b: People with stroke and therapists will identify strategies that 
support safety during remotely delivered post-stroke intervention (intervention 
interview, study exist interview). 
Aim 2: Optimize proposed trial study procedures (teleABLE intervention, 
assessment procedures) to enhance acceptability of trial design. 
Hypothesis 2a: People with stroke will indicate satisfaction with teleABLE 
procedures (Client Satisfaction Questionnaire-8 mean item score ≥3). 
Hypothesis 2b: People with stroke will recommend adaptations to intervention 
delivery and assessment sessions that optimize the study protocol (study exit 
interview). 
2.0 
Background 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 6 of 44 
Template Revised On: 10/28/2022 
2.1 Significance of Research Question/Purpose: Sedentary lifestyles are prevalent 
among the 7 million Americans who have survived stroke, placing them at 
elevated risk for poor health outcomes [1, 2]. Approximately 81% of stroke 
survivors have at least one comorbid chronic condition, which elevated their risk 
for primary stroke and contributes to their ongoing risk for recurrent stroke [3]. 
These conditions – heart disease, hypertension, diabetes, depression, and chronic 
obstructive pulmonary disorder – persist and their management is compromised 
by sedentary behavior [4-8]. Reducing sedentary behavior is particularly 
important for promoting health in the context of stroke-related disability [9]. 
Even if impairments fully resolve, stroke survivors do not automatically re-engage 
in non-sedentary activities as impairments diminish [10]. Further, residual 
impairments, social influences (protective support persons), and environmental 
factors (transportation, accessibility) create barriers to engagement in personally 
meaningful non-sedentary daily activities [11-15]. 
2.2 Preliminary Data: The PI led the development and feasibility testing of the ABLE 
intervention targeting post-stroke sedentary behavior [16, 17]. Feasibility testing 
in 20 people with chronic stroke demonstrated that ABLE delivered in-person was 
safe, well tolerated, and able to be delivered by multiple therapists with high 
fidelity to the treatment protocol [17]. These promising results form the basis for 
the present research. 
2.3 Existing Literature: Interventions targeting post-stroke sedentary behavior are 
scant. Interventions that promoted adults’ adherence to physical activity were 
less effective for reducing sedentary behavior than those specifically designed to 
reduce sedentary behavior [18]. Our systematic review of interventions that 
measured sedentary behavior or daily physical activity engagement as an 
outcome revealed only two interventions that specifically aimed to modify post-
stroke sedentary behavior [19]. The first (unnamed) employed motivational 
interviewing and action planning [20], while the second (STUFFS) used action 
planning in combination with feedback via an activity monitoring device [21]. To 
our knowledge, ABLE is the third intervention that specifically aims to reduce 
post-stroke sedentary behavior. The first two interventions facilitated physical 
activities (standing, walking, stepping, sit-to-stand exercise) during times when 
participants were at risk for sitting. A pilot randomized controlled trial of the 
motivational interviewing intervention demonstrated no between-group 
differences in sedentary behavior change relative to an attention control group 
which received diet advice. This intervention used a low dose (4 sessions 
delivered over 7 weeks) to achieve a 39.2 minutes per day within-group reduction 
in prolonged sitting [20]. It is likely that stroke survivors, who are adjusting to 
disability, require more structure, repetition, and intensity to achieve goals than 
adults without newly acquired disability. A single group feasibility study examined 
the STUFFS intervention during subacute stroke and demonstrated within-group 
reduction in sedentary time of 54.2 minutes per day, which diminished to 26.8 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 7 of 44 
Template Revised On: 10/28/2022 
minutes per day at 8-week follow-up [21]. These findings are similar to results 
from the preliminary ABLE study.  
The proposed adaptations to ABLE will build on existing literature. First, ABLE will 
be delivered earlier in the rehabilitation process than previously delivered. 
Sedentary lifestyles are established during the first year after stroke and persist 
through the chronic phase of stroke [22-24]. Delivering ABLE during this first year 
will capitalize on a period during which stroke survivors adopt new routines and 
seek strategies to reduce recurrent stroke risk [25, 26]. Second, ABLE will be 
delivered via telehealth (videoconference). Because participants complete 
scheduled activities between sessions, intervention sessions are primarily 
conversation-based. Thus, ABLE is readily adaptable to telehealth delivery 
(teleABLE), which will expand reach and access. Further, the COVID-19 pandemic 
accelerated support for implementation of telerehabilitation models [27, 28]. 
Simultaneously, this highlighted the need for evidence of safe and effective 
telerehabilitation interventions in stroke [29-33].  
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: The primary outcome of this research is 
participant satisfaction as measured by:  
● Client Satisfaction Questionnaire-8 at week 8.  
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): The secondary outcomes of this 
research focus on feasibility metrics and within-person change in behavioral 
outcomes. 
● Safety measured by documentation of treatment-related serious (e.g. 
injurious) and non-serious (e.g. fall without injury) adverse events that 
occur during the intervention period (weeks 2 through 7). 
● Enacted behavioral treatment dose measured by documentation of 
intervention session attendance (weeks 2 through 7). 
● Participation restrictions measured using the Activity Card Sort 3 (week 
8). 
● Health-related quality of life measured using the EuroQoL-5 Dimension-
5 Level (week 8). 
● Sedentary minutes measured using the activPAL micro3 monitor 
following an 8-day wear protocol (week 8).  
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description: The structural and active elements of the teleABLE intervention are 
described in Table 1. teleABLE is adapted from the ABLE intervention. ABLE is a 
tailored intervention that enables stroke survivors to overcome barriers to 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 8 of 44 
Template Revised On: 10/28/2022 
engagement in their own personally meaningful non-sedentary activities. 
Grounded in behavioral activation, ABLE was developed with the underlying 
assumptions that: 1) stroke survivors consciously or subconsciously do not return 
to personally meaningful activities perceived as having potential to result in 
discomfort or failure (experiential avoidance), and 2) successful participation in 
personally meaningful non-sedentary activities is motivating to engage in non-
sedentary activities. Additionally, sedentary behavior interventions in similarly at-
risk populations demonstrated the efficacy of activity scheduling and activity 
monitoring which align with the behavioral activation framework [34-36]. 
The intervention process is described in Table 2. Sessions 1 and 2 are focused on 
providing education regarding sedentary behavior, building awareness of 
personal sedentary behavior patterns, and identifying non-sedentary activities 
that are personally meaningful. The remaining sessions include an iterative 
process during which stroke survivors iteratively apply a 4-step strategy (ICAN 
Plan) that activates engagement in these non-sedentary daily activities. 
Participants Identify a time when they are at risk for sitting, Choose an 
instrumental or daily activity to complete during that time, and create a specific 
plan to Adapt the activity by identifying solutions to anticipated barriers, and 
safety concerns. Participants are instructed to carry out the plan between 
sessions and Notice aspects of the plan that worked well or that may require a 
modified plan. Participants also notice how they felt during and after completing 
the activity. Within the Adapt step, participants are directly prompted to consider 
the safety of the activity and to develop a plan to assure safety. Therapists will 
follow the teleABLE Safety Algorithm (included with submission) to support 
participant dignity and safety. The ICAN process is documented on worksheets 
provided in the teleABLE workbook. This process guides participants through 
monitoring, scheduling, problem solving, and self-assessing activity engagement. 
This strategy enables teleABLE to be individualized to overcome participants’ 
specific impairment and environmental barriers to engagement in preferred non-
sedentary activities. 
Table 1. teleABLE intervention elements. 
Structural 
Elements 
Clinician: Occupational therapist 
Environment: Videoconferencing (e.g., Zoom) 
Dose: 2x/week for 6 weeks (12 sessions) 
Materials: teleABLE workbook 
Active 
Elements 
Activity Scheduling: Plan established to complete a specific 
activity at a specific time. 
Activity Monitoring: Identification of activity that occurred 
during waking hours. 
Self-Assessment: Explicit identification of positive and 
negative outcomes of activity engagement 
Problem Solving: Participant-generated solutions to 
challenges identified. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 9 of 44 
Template Revised On: 10/28/2022 
The teleABLE intervention will be delivered remotely using the University of 
Minnesota Health Care Component Zoom account which is HIPAA-compliant and 
will be accessed via their own personal device. Sessions will be delivered by a 
research assistant who is trained and supervised by the PI (a nationally certified 
and state-licensed occupational therapist). Participants will complete 2 sessions 
per week over 6 weeks (12 total sessions). Sessions 1 and 3 to 12 are expected to 
last approximately 30 minutes each. Session 2 may last up to 60 minutes. A 
teleABLE workbook and technology manual will be mailed to participants prior to 
the first intervention session. 
4.2 
Drug/Device Handling: N/A 
4.3 
Biosafety: N/A 
4.4 
Stem Cells: N/A 
4.5 
Fetal Tissue: N/A 
 
5.0 
Procedures Involved 
5.1 Study Design: This study uses a sequential case series design to refine the 
intervention and study protocol based on feedback from participants and the 
treating therapists. Participants will complete assessments at Baseline (week 1) 
and 2-months (week 8), participate in 12 intervention sessions over 6 weeks 
(weeks 2 through 7), and complete 2 interviews (mid-intervention and week 8). 
Participants will also wear an activPAL activity monitor for 8 days at baseline and 
2-months to assess sedentary behavior.  
5.2 Study Procedures: Participants will be recruited through Courage Kenny 
Rehabilitation Institute, community-based recruitment, and Fairview Health 
System (see section 11.1 to 11.3). Interested potential participants will complete 
a screening questionnaire over the telephone (see section 8.3). Those deemed 
eligible will meet with study staff to review the informed consent document and 
have an opportunity to ask questions before deciding whether they want to 
consent to participate in the study. Participants who choose to provide consent 
Table 2. teleABLE intervention process 
Week 
Session 
Content 
Homework 
1 
1 
Overview: 
• What is sedentary behavior? 
• Modifying sedentary behavior patterns 
• Self-monitor 1 day 
2 
• Reflection: activPAL data, self-monitoring 
• Brainstorm non-sedentary activities 
• Introduce ICAN Plan 
• Carry out ICAN Plan 
• Self-monitor 1 day 
2 to 6 
3 to 12 
Iterative process: 
• Self-Assessment of ICAN Plan, 
• Modify existing ICAN Plan, or 
• Develop new ICAN Plan  
• Carry out ICAN Plan 
• Self-monitor 1 day 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 10 of 44 
Template Revised On: 10/28/2022 
will complete eConsent (see section 21.1). After providing consent, the 
participant will be scheduled to complete the baseline testing session. The 
schedule of measures is depicted in Table 3. All study procedures, including 
assessments and intervention sessions, will be conducted remotely using 
videoconferencing (HIPAA-compliant University of Minnesota Health Care 
Component Zoom). The study staff administering each questionnaire will display 
the questions and response options on the Zoom screen. In addition, study staff 
may read the questions aloud if the participant prefers. The participant will 
provide a verbal response for all measures. All procedures will be conducted for 
research purposes.  
Table 3: Schedule of Measures 
 
W1 
W2 
W3 
W4 
W5 
W6 
W7 
W8 
Technology Questionnaire (5 
min) 
X 
 
 
 
 
 
 
 
EuroQoL-5D-5L (5 min) 
X 
 
 
 
 
 
 
X 
Activity Card Sort (30 min)  
 
X 
 
 
 
 
 
X 
Acceptance and Action 
Questionnaire-II (5 min) 
X 
 
 
 
 
 
 
X 
Survey of Activities and Fear of 
Falling in the Elderly (5 min) 
X 
 
 
 
 
 
 
X 
Social Problem Solving 
Inventory-Revised Short Form 
(10 min) 
X 
 
 
 
 
 
 
X 
General Self Efficacy Scale (5 
min) 
X 
 
 
 
 
 
 
X 
Neuro-QOL Item Bank Short 
Forms (10 min) 
X 
 
 
 
 
 
 
X 
5-Times Sit-to-Stand Test (5 
minutes) 
X 
 
 
 
 
 
 
 
30-Second Sit-to-Stand Test (5 
minutes) 
X 
 
 
 
 
 
 
 
Client Satisfaction 
Questionnaire-8 (5 minutes) 
 
 
 
 
 
 
 
X 
Demographic Interview (5 min) 
X 
 
 
 
 
 
 
 
Stroke History Interview (5 min) 
X 
 
 
 
 
 
 
 
Self-Administered Comorbidity 
Index (5 min) 
X 
 
 
 
 
 
 
 
Montreal Cognitive Assessment 
(5 min) 
X 
 
 
 
 
 
 
 
Dyadic Adjustment Scale-7 (3 
min) 
X 
 
 
 
 
 
 
 
Inclusion of Others in Self Scale 
(3 min) 
X 
 
 
 
 
 
 
 
Supervised blood pressure (10 
minutes during assessments) 
X 
 
 
 
 
 
 
X 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 11 of 44 
Template Revised On: 10/28/2022 
Unsupervised blood pressure (3 
min/day for 7 days) 
X 
 
 
 
 
 
 
X 
activPAL 8-day monitoring (10 
min instruction, 2 min/day) 
X 
 
 
 
 
 
 
X 
Interview 1 (30 min) 
 
 
 
X 
 
 
 
 
Interview 2 (30 min) 
 
 
 
 
 
 
 
X 
NOTE: W=Week; Study intervention is delivered during weeks 2 through 7. 
Measures: 
• Technology Questionnaire: This is a 12-item questionnaire that was designed 
based on our team’s findings from a prior Zoom-based intervention for people 
with stroke (Kringle et al., in press). Participants indicate their confidence 
using their device and the software, indicate their current approach to each 
step required to join a Zoom call, and indicate their preferences for learning 
new technologies. The information gleaned from this questionnaire is used by 
the study team to support study participants throughout remote interactions 
that occur throughout the study. 
• EuroQoL-5D-5L: This is a valid and reliable measure of health related quality 
of life among people with stroke and other at-risk populations. Participants 
rank their function on 5 items (mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression) using a 5-point Likert-type scale. 
Participants also rate how good or bad their overall health is at the time of 
assessment using a 0 to 100 scale [37, 38]. 
• Activity Card Sort: This is a valid and reliable measure of activity restriction 
among adults with stroke and disability. We will use the electronic version of 
this tool during which participants view photos of 100 everyday activities and 
categorize activities into those they a) never did, b) do less, c) gave up, d) do 
now, or e) want to start since the time of their stroke. For activities that the 
participant indicates that they do less, gave up, or want to start, they are 
asked to respond to the question: “Given where we’re at with COVID and the 
effects of your stroke, how confident would you be if you did that activity 
today, from 1 (not at all confident) to 10 (extremely confident)?” Participants 
are asked to provide a rationale for their confidence level [39]. 
• Acceptance and Action Questionnaire-II: This is a valid and reliable measure 
of experiential avoidance among adults. Participants rank 7 statements 
regarding their emotions and worry on a 7-point Likert-type scale. Scores are 
summed, with high scores indicating high experiential avoidance [40]. 
• Survey of Activities and Fear of Falling in the Elderly: This is a valid and 
reliable questionnaire that assesses participation in 11 daily activities, and the 
degree to which fear related to falling is the reason for restricted 
participation. For each activity, participants identify: a) if they currently do the 
activity (yes/no), b) fear that they might fall while doing the activity using a 4-
point Likert-type scale, c) reasons besides falling for avoiding or not doing the 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 12 of 44 
Template Revised On: 10/28/2022 
activity, and d) amount of performance of the activity relative to 5 years ago. 
Scores are reported as participation restriction, mean fear scores, and can be 
used to classify participants based on fear of falling and activity restriction 
[41, 42]. 
• Social Problem-Solving Inventory-Revised Short Form: This is a brief measure 
of problem-solving approaches that has been validated against longer 
versions of the Social Problem-Solving Inventory. Participants will respond to 
25 statements describing their approach to solving daily problems on a 0 (not 
at all true of me) to 4 (extremely true of me) Likert-type scale. A composite 
problem-solving score is derived by reverse scoring negative problem-solving 
domains (negative problem orientation, impulsive/careless style, avoidance 
style) and summing all scores. High scores (out of a possible 40) represent 
greater problem-solving abilities [43]. 
• General Self Efficacy Scale: This is a valid and reliable measure of self-efficacy 
for navigating daily life situations. Participants rate 10 statements using a 1 
(not at all true) to 4 (extremely true) Likert-type scale. Scores are summed, 
and high scores indicate high self-efficacy [44]. 
• Client Satisfaction Questionnaire-8: This is a valid and reliable measure of 
client satisfaction with the treatment received. Participants rate 8 statements 
on a 1 to 4-point Likert-type scale. High scores indicate high satisfaction [45]. 
• Demographic Interview: These characteristics will be obtained during 
participant interview. We will obtain the following: sex, gender identity, age, 
race/ethnicity, education, employment status, occupation, presence/absence 
of support person, living situation (e.g., alone, with or without support 
person) 
• Stroke History Interview: These characteristics will be obtained during 
participant interview. Participants will report the date, type (ischemic vs. 
hemorrhagic), and side of their stroke, the types of healthcare services that 
they received after their stroke, and whether their current activity level is 
higher, lower, or the same relative to pre-stroke levels. 
• Self-Administered Comorbidity Questionnaire: This is a valid and reliable 
measure of comorbidities. Participants will indicate the presence or absence 
of 14 common chronic conditions (yes/no). For each condition present, 
participants will indicate if they are currently receiving treatment for the 
condition (yes/no), and if the condition limits their daily life activities (yes/no). 
One point is assigned to each affirmative response. The severity score is 
computed by summing all responses (possible scores 0 to 42). High scores 
indicate high comorbidity severity [46]. 
• Neuro-QoL Item Bank Short Forms: Upper Extremity Function (Fine Motor, 
ADL), Lower Extremity Function (Mobility), Cognition Function, 
Communication, Depression, and Anxiety will be assessed via self-report 
questionnaire. Each domain is measured using a short form where 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 13 of 44 
Template Revised On: 10/28/2022 
participants rank their function on 5 to 8 items using a 5-point Likert-Type 
scale. Scores are summed and converted to T-scores which are interpreted 
relative to the general population (M=50, SD=10). The Neuro-QOL short forms 
are valid and reliable measures of the identified constructs in people with 
stroke [47]. 
• 5-Times Sit-to-Stand Test: During this performance-based test of lower 
extremity strength, participants will be instructed to begin from a seated 
position in a chair without wheels. They will then be instructed to stand up 
and sit down 5 times as quickly as possible. The length of time that it takes to 
complete 5 sit-to-stands will be recorded. This is a valid and reliable measure 
of lower extremity strength among people with stroke [48]. 
• 30-Second Sit-to-Stand Test: During this performance-based test of lower 
extremity strength, participants will be instructed to begin from a seated 
position in a chair without wheels. They will then be instructed to stand up 
and sit down as many times as they can within 30 seconds. The count of full 
sit-to-stand cycles will be recorded. This is a valid and reliable measure of 
lower body strength among community-dwelling older adults [49]. 
• Montreal Cognitive Assessment (MoCA): The 5-minute MoCA protocol is a 
valid and reliable screening tool for assessment of vascular cognitive 
impairment that was developed to be administered via teleconferencing. This 
is a performance-based measure where participants complete 5-word 
learning, verbal fluency, orientation to time and place, and 5-word recall 
tasks. Each item is scored by the assessor and summed (possible range 0 to 
30, low scores indicate greater impairments) [50]. 
• Dyadic Adjustment Scale-7: This is a valid and reliable measure of 
interpersonal relationships that has been used to assess caregiver-care 
recipient relationships in stroke. This questionnaire contains 7 items rated on 
a 6-level ordinal scale describing the extent of agreement or disagreement, 
frequency of interactions, and happiness in relationships [51-53]. 
• Inclusion of Other in Self Scale: This is a valid and reliable 2-item measure 
that describes the closeness of interpersonal relationships. Participants select 
one of 7 images which best represent their relationship with their support 
person and, separately, their community [54]. 
• Supervised Blood Pressure: Blood pressure measurements will be taken 
during the remote assessment session following best practices recommended 
by the American Heart Association and procedures in previously published 
trials [55, 56]. Prior to the session, participants will receive an Omron Series 5 
Upper Arm blood pressure monitor in the study package that will be mailed. 
Participants will be instructed to abstain from caffeine, nicotine, alcohol, and 
food for 1 hour prior to the assessment session. During the session, the 
assessor will verify abstentions. If the abstentions were not followed prior to 
the session, the assessor will ask the participant to abstain from caffeine, 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 14 of 44 
Template Revised On: 10/28/2022 
nicotine, alcohol, and food for the next hour and proceed with the remaining 
assessments. They will then complete the supervised blood pressure measure 
after at least one hour has passed. Participants will be instructed in proper 
use the Omron Upper Arm blood pressure monitor. They will complete a 5-
minute rest, followed by 3 blood pressure measurements with a 1-minute rest 
between each measure. In addition to documenting the systolic and diastolic 
blood pressure readings, the arm that was used to take the reading 
(left/right), most recent time any blood pressure medication was taken, and 
type and dose of blood pressure medication will be documented. 
• Unsupervised Blood Pressure: During the same time period during which 
participants are wearing the activPAL monitor, they will be asked to document 
their morning blood pressure reading following a procedure based on the 
American Heart Association guidelines for self-measured blood pressure 
monitoring [55]. Participants will use the Omron Upper Arm blood pressure 
monitor that they received in the mail. During the Baseline (week 1) 
assessment session, they will be instructed in proper use of the monitor. 
Participants will be asked to take 1 blood pressure reading when they first get 
up in the morning. They will document each reading, the time of the reading, 
and if blood pressure medication was taken, the time, dose, and type of 
medication in the Daily Diary. 
• activPAL 8-day monitoring: The activPAL micro3 (Pal Technologies, Glasgow) 
will be used to measure sedentary behavior. The activPAL micro3 contains a 
triaxial accelerometer and inclinometer which detects and records posture 
throughout the day (sitting/reclined/lying, standing). A validation study in 
people with and without stroke revealed 100% accuracy for postural 
detection relative to video observations [57]. We will follow a 24-hour, 8-day 
wear protocol that we previously deployed in preliminary studies examining 
post-stroke sedentary behavior [17, 58]. The device will be activated via 
microUSB cable, using activPAL3 Software. The device will then be 
waterproofed following recommendations from the manufacturer and mailed 
to the participant with all required materials for application. During the virtual 
baseline testing session, each participant will be instructed in how to adhere 
the device to the anterior aspect of his/her non-stroke thigh using a gentle 
medical-grade tape [59, 60]. With the device, participants will also receive 
educational information regarding the device, self-monitoring to assess for 
skin irritation, and steps to take should skin irritation be identified (remove 
the device, contact the PI). Participants will also record sleeping and non-wear 
time using a daily diary provided by the research team. After the monitoring 
period is completed, participants will return the device and daily diary to the 
laboratory using a pre-addressed and postage paid mailer provided by the 
research team. No identifying information is recorded within the device. Upon 
receipt of the device, raw activity monitor data will be uploaded to the study 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 15 of 44 
Template Revised On: 10/28/2022 
Box folder using activPAL3 Pal Analysis Software (v.8, Pal Technologies, 
Glasgow) and processed using a diary-informed protocol [58, 61]. 
• Interview 1: This interview will be conducted within 14 days after session 5 
and focus on the participants’ perspectives on: 1) learning to use 
videoconferencing in the context of the teleABLE intervention, 2) accessing 
videoconferencing, and 3) ways that the therapist and/or support person 
support their use of videoconferencing during the study. The interview will be 
conducted by a research assistant supervised by the PI. We anticipate that the 
interview will last 30 to 60 minutes. Interviews will be audio recorded using 
the Zoom record function. The resulting audio file will be stored in the study’s 
UMN BOX folder. Interviews will be transcribed by a company called Research 
Transcriptions (previously SameDayTranscriptions). Research Transcriptions 
provides confidential transcription services, using HIPAA-compliant 
procedures. Interviews will be transcribed in batches based on data 
accumulation. Deidentified transcripts will be stored in the study’s UMN BOX 
folder.  
• Interview 2: This interview will be conducted during the post-intervention 
assessment session after study measures are completed and will focus on 
participants’ perspectives on the intervention, study recruitment, assessment, 
and intervention procedures that may enhance retention in future trials. 
Interviews will be audio recorded using the Zoom record function. The 
resulting audio file will be stored in the study’s UMN BOX folder. Interviews 
will be transcribed by a company called Research Transcriptions (previously 
SameDayTranscriptions). Research Transcriptions provides confidential 
transcription services, using HIPAA-compliant procedures. Interviews will be 
transcribed in batches based on data accumulation. Deidentified transcripts 
will be stored in the study’s UMN BOX folder. 
5.3 Study Duration: Individual participants’ study participation will occur over 8 
weeks. Assessment sessions will occur during weeks 1 and 8 (2 hours per session). 
During the 8-day monitor wear that occurs during weeks 1 and 8, participants 
may spend up to 5 minutes daily completing the activPAL diary worksheet. 
Intervention sessions 1 and 3 through 12 will last 30 minutes each. Intervention 
session 2 will last 60 minutes. Interview 1, which occurs during week 5, will last 30 
minutes.  
We anticipate the participants will be recruited and complete all study 
procedures over 10 months. Data analysis will require an additional 4 months 
after all data are collected.  
5.4 Use of radiation: N/A 
5.5 Use of Center for Magnetic Resonance Research: N/A  
6.0 
Data and Specimen Banking 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 16 of 44 
Template Revised On: 10/28/2022 
6.1 Storage and Access: Data collected for research purposes will be identified by a 
unique study ID code and stored in REDCap (questionnaires), Excel (activPAL 
data), and transcribed word processing files (audiorecorded interviews). These 
data will be stored separately from the linking form in REDCap, which is the only 
location where the participants’ names will be stored with their study ID codes. 
All fields on the linking form will be marked as identifier fields in REDCap, and the 
REDCap database will be set to only allow deidentified fields to be exported. 
Audiorecorded data (interviews, intervention sessions), activPAL data, and 
REDCap data exports will be stored in the University Box Secure Storage. Only 
approved researchers who require access to the data to conduct assessments, 
intervention, or analyses will be granted access to the data. Data will be 
maintained in this manner until analyses are completed. The study linking form 
will be destroyed after all data are collected, verified, and analyzed. 
6.2 Data: Data stored for future use are: 
• Deidentified questionnaire-based data describing: health-related quality of life 
(EuroQoL-5D-5L), activity restrictions (Activity Card Sort), experiential avoidance 
(Acceptance and Action Questionnaire-II), activity avoidance (Survey of Activities 
and Fear of Falling in the Elderly), problem-solving approaches (Social Problem-
Solving Inventory-Revised Short Form), self-efficacy (General Self Efficacy Scale), 
demographic data (sex, gender identity, age, race/ethnicity, education, 
employment status, occupation, presence/absence of support person, living 
situation), stroke characteristics (date, type, side of stroke, types of healthcare 
services received after stroke, activity level relative to pre-stroke), comorbidities 
(Self-Administered Comorbidity Index), functioning (Neuro-QOL Lower Extremity 
Function, Upper Extremity Function, Cognition Function, Communication, 
Depression, Anxiety), cognition (Montreal Cognitive Assessment), interpersonal 
relationship (Dyadic Adjustment Scale-7, Inclusion of Others in Self Scale). 
• Deidentified activPAL monitoring data stored as .csv and .pal files 
• Deidentified transcripts of interviews 1 and 2 
• Audiorecorded intervention sessions 
6.3 Release/Sharing: Although there are no current plans for data sharing, requests 
for data sharing will be directed to the PI and deidentified data will be provided 
upon reasonable request through appropriate channels (i.e., Data Use 
Agreement).  
7.0 
Sharing of Results with Participants 
7.1 Individual participant results may be shared with participants at 2 points during 
the study. (1) During baseline testing, the Neuro-QOL Depression Short Form is 
administered, which is a validated measure of depressive symptom load in the 
stroke population [62]. A raw score of ≥26 on this measure indicates that the 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 17 of 44 
Template Revised On: 10/28/2022 
participant is experiencing severe depressive symptoms. If the participant meets 
or exceeds this score of 26 on this measure, the study team will verbally discuss 
the results with the participant, provide the participant with a packet (via 
electronic mail) which contains mental health crisis support information and an 
education sheet on mental health after stroke published by the American 
Congress of Rehabilitation Medicine, and encourage the participant to discuss 
these symptoms with their primary care physician. (2) At the post-intervention 
assessment timepoint, each participant will be offered the option to schedule a 
15-minute meeting with the PI to view and discuss their individual results on the 
primary clinical outcomes (health-related quality of life, activity restrictions, 
activPAL sedentary time, activPAL step count).  
Study results: Aggregate study results will be shared with participants in the form 
of a study newsletter shared after the results have been analyzed and accepted 
for publication in a peer-reviewed journal. This newsletter will contain a plain 
language summary of the findings and a link to the peer-reviewed publication.  
7.2 Sharing of genetic testing:  
7.2.1 Disclosure of results: N/A: This study does not involve genetic testing 
7.2.2 If returning results to participants: 
N/A: This study does not involve genetic testing 
● Aggregate or individual results: N/A: This study does not involve genetic 
testing 
● Laboratory results: N/A: This study does not involve genetic testing 
● Plan for return of results to participants: N/A: This study does not involve 
genetic testing 
● Types of results to be returned to participants: N/A: This study does not 
involve genetic testing  
7.2.3 Future analysis of genotypes: N/A: This study does not involve genetic 
testing  
8.0 
Study Population 
8.1 Inclusion Criteria:  
• Age: 18 years or older 
• Diagnosis: Stroke diagnosis ≤12 months prior to study enrollment 
• ≥6 hours of sedentary behavior on a typical weekday (Sedentary Behavior 
Questionnaire) [63]  
• Ambulatory with or without assistive device (assessed by Functional 
Independence Measure, mobility score ≥5) [64] 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 18 of 44 
Template Revised On: 10/28/2022 
• Able to access an electronic device (smartphone, tablet, or computer) that is 
compatible with a videoconferencing application 
• Able to identify a support person with whom they have face-to-face interaction 
at least one time per week 
• Able and willing to participate fully in the study and provide informed consent 
8.2 Exclusion Criteria:  
• Currently receiving care in an inpatient rehabilitation, transitional care 
unit, or skilled nursing facility 
• Severe cognitive or communication impairments (inability to respond 
accurately to complete study telephone screening or complete 
informed consent) 
• Comorbid neurodegenerative disorder (e.g. Parkinson’s disease, 
multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, 
dementia, Alzheimer’s disease, Huntington’s disease, glioblastoma) 
• Comorbid cancer, currently undergoing chemotherapy or radiation 
treatment 
• Comorbid major depressive disorder (Patient Health Questionnaire-2, 
score ≥2) [65] 
• Received inpatient treatment or hospitalized for psychiatric condition 
and/or alcohol or substance abuse within the past 12 months 
• Diagnosis of a terminal illness and/or currently receiving hospice care 
• Currently pregnant or expecting to become pregnant in the next 8 
weeks. 
• History of skin sensitivity that precludes the use of medical tape 
necessary for adherence to activity monitor measure 
• Inability to speak, read, or understand English 
• Concurrent participation in any other rehabilitation intervention 
research study (including cognitive and/or physical rehabilitation 
studies) 
• Investigator discretion for safety or adherence reasons 
8.3 Screening: Volunteers who express interest in study participation will complete a 
telephone screening telephone call to determine eligibility. The PI or a research 
assistant trained and supervised by the PI (a licensed occupational therapist with 
over 10 years of experience in post-stroke assessment and intervention) will 
follow a screening script that (1) describes the study, and (2) confirms the 
volunteer’s interest in completing study screening. If the volunteer expresses 
interest, we will obtain verbal consent to conduct telephone screening. 
Documentation of (1) verbal consent for screening, and (2) responses to study 
screening questions will be recorded electronically in REDCap. Volunteers will be 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 19 of 44 
Template Revised On: 10/28/2022 
asked questions to determine eligibility based on the eligibility criteria listed in 
8.1 and 8.2.  
9.0 
Vulnerable Populations 
University requirements for inclusion of vulnerable populations may be stricter than 
what may be acceptable for sponsors or for lead investigators at other institutions. 
9.1 Vulnerable Populations:  
Identify which of the following populations will be allowed to participate in this 
study. You may not include members of the populations below as participants in 
your research unless you indicate this in your inclusion criteria above. Inclusion of 
an individual from one of these groups will require the investigator to develop 
additional safeguards (Section 9.2) proportional to the degree of vulnerability and 
proportional to the degree of risk and benefit. 
 
Population / Group 
Identify whether any of the following 
populations will be focus of the 
research (targeted), included, but not 
necessarily the focus or excluded 
from participation in the study. 
Children 
Excluded 
Pregnant women/fetuses/neonates 
Excluded 
Prisoners 
Excluded. 
Adults lacking capacity to consent 
and/or adults with diminished capacity 
to consent, including, but not limited 
to, those with acute medical conditions, 
psychiatric disorders, neurologic 
disorders, developmental disorders, 
and behavioral disorders 
Excluded 
Non-English speakers 
Excluded 
Those unable to read (illiterate) 
Excluded 
Employees of the researcher 
Excluded 
Students of the researcher 
Excluded 
Undervalued or disenfranchised social 
group 
included but not the focus. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 20 of 44 
Template Revised On: 10/28/2022 
Active members of the military (service 
members), DoD personnel (including 
civilian employees) 
included but not the focus. 
Individual or group that is approached 
for participation in research during a 
stressful situation such as emergency 
room setting, childbirth (labor), etc. 
Excluded 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
included but not the focus 
Individual or group with a serious 
health condition for which there are no 
satisfactory standard treatments. 
Excluded 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
included but not the focus 
Any other circumstance/dynamic that 
could increase vulnerability to coercion 
or exploitation that might influence 
consent to research or decision to 
continue in research. 
included but not the focus. 
 
9.2 Additional Safeguards, if any, to ensure inclusion is appropriate:  
We will recruit participants with mild stroke who spend ≥6 hours/day sitting and 
who demonstrate the cognitive and communication ability to provide informed 
consent. Although not the direct focus of recruitment, this population contains 
and, to more closely reflect the stroke population, we are not excluding 
volunteers who are (1) undervalued or disenfranchised in society [e.g. BIPOC, 
disability community, LGBTQ], (2) active members of the military and/or DoD 
personnel, (3) individuals who are disadvantaged in the distribution of social 
goods and services such as income, housing, or healthcare, (4) individuals with 
fear of negative consequences for not participating in the research [e.g. 
undocumented immigrants], and (5) another circumstance/dynamic that could 
increase vulnerability to coercion or exploitation [i.e., insurance no longer 
covering post-stroke rehabilitative services due to plateau in progress or cap in 
coverage, unable to afford cost of rehabilitative services].  

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 21 of 44 
Template Revised On: 10/28/2022 
We have in place the following safeguards to ensure that potential research 
participants fully understand the research and are free to decline joining the 
study: (1) During telephone recruitment study description, screening, and 
informed consent meetings, we will emphasize that the study intervention, 
though delivered by an occupational therapist, is not traditional rehabilitative 
services, (2) We will provide the informed consent document via either electronic 
or hard copy prior to the consent meeting to provide volunteers and their support 
persons ample time to review the document and identify questions, (3) We will 
encourage volunteers who screen eligible to invite a support person to the 
informed consent meeting where the full details of study involvement are 
provided and questions will be invited and answered, (4) During the consent 
meeting, we will emphasize the voluntary nature of the research including 
information on how to withdraw from the study at any point, provide information 
on alternative community programs (e.g., community fitness classes) that may 
facilitate post-stroke physical activity, and provide ample time for questions and 
discussion. We will also offer time for the volunteer to discuss the research with 
whomever they choose (e.g., support person, physician) without the researcher 
present, (5) Prior to signing the consent document, the volunteer will be required 
to complete teach-back describing the purpose of the study, what they will be 
asked to do, study risks, and how to withdraw should they choose to do so, (6) 
We will not screen for or ask about immigration status, illegal or stigmatizing 
behaviors, or military status at any point during the study. Therefore, the 
participant’s status is unlikely to be known to the research team. We do not 
anticipate vulnerability for any of these groups to be increased by participating in 
this study. 
9.3 If research includes potential for direct benefit to participants, provide rationale 
for any exclusions indicated in the table above: 
The following populations are excluded from this study: 
• Children: The behavioral intervention is designed for an adult population 
and is, therefore not developmentally appropriate for pediatric stroke 
survivors (i.e., cerebral palsy). 
• Pregnant women/fetuses/neonates: Sedentary behavior, daily activity 
patterns, and barriers to non-sedentary behavior in pregnant women 
differ from the general population [66]. Including pregnant women would 
prevent accurate interpretation of the data in such a small pilot study. 
• Prisoners: The behavioral intervention is designed for a community-based 
free living population, which is not reflected in a prisoner population. 
• Adults lacking capacity to consent and/or adults with diminished capacity 
to consent: Adherence to the behavioral intervention requires cognitive 
ability to follow through and make safe judgements when enacting plans 
between sessions. People with post-stroke cognitive impairments may 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 22 of 44 
Template Revised On: 10/28/2022 
require a more closely supervised or in person approach to post-stroke 
sedentary behavior intervention than this intervention provides. 
• Non-English speakers: The participant workbook is only available in English 
and the study team does not contain individuals who are fluent in other 
languages. Therefore, because of the discussion-based nature of the 
intervention, we are unable to feasibly include non-English-speakers at 
this time. 
• Those unable to read (illiterate): The behavioral intervention requires 
reading participant workbook materials and writing down plans to refer to 
between sessions. 
• Employees of the researcher: Students of the researcher are excluded to 
minimize the risk for power dynamics in the employee-employer 
relationship that may bias feedback on the intervention approach and 
outcomes measures. 
• Students of the researcher: Students of the researcher are excluded to 
minimize the risk for power in the student-professor relationship to bias 
feedback on the intervention approach and outcomes measures. 
• Individual or group that is approached for participation in research during 
a stressful situation: This intervention is designed to be delivered during 
the sub-acute and post-acute phase of stroke. Therefore, volunteers will 
not be approached for participation in this research during a stressful 
situation. 
• Individual or group with a serious health condition for which there are no 
satisfactory standard treatments: People with serious health conditions 
for which there are no satisfactory standard treatments are excluded 
under our comorbidities-related exclusion criteria, because these 
conditions differentially impact the clinical study outcomes (health-related 
quality of life, activity restrictions, sedentary behavior). 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented:  
Lowest number that will allow data analysis: 5 participants 
Maximum that might agree to participate: 15 participants. 
We are aiming to recruit 5 to 10 participants who will complete the entire study. 
We have expanded this maximum number to 15 to allow for study withdrawals. 
11.0 Local Recruitment Methods 
11.1 Recruitment Process:  
Courage Kenny Rehabilitation Institute (CKRI): CKRI therapists and care 
coordinators will be asked to share the study flyer with past or current patients 
who meet inclusion/exclusion criteria. Prospective participants who are 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 23 of 44 
Template Revised On: 10/28/2022 
interested in exploring enrollment will be instructed by CKRI therapists to contact 
the DWELL Research Laboratory via either telephone or email using the 
information contained on the flyer. All email contact during recruitment is limited 
to providing more information about the study and possibly scheduling a time for 
the telephone screening call. CKRI therapists will also ask patients who indicate 
interest for permission to share their first and last name and telephone number 
with the DWELL Research Laboratory staff. If the patient provides permission, 
CKRI therapists will email the patient’s information to the DWELL study team.  
Community recruitment: We will also post information about the study on the 
DWELL Laboratory Website (https://dwell.umn.edu), StudyFinder, invite 
community-based stroke support groups to share study flyers with their 
members, and distribute study flyers at DWELL Lab community engagement 
events (e.g., Driven to Discover Research space at the Minnesota State Fair and 
county fairs). 
Fairview Health System: We will mail study invitation letters to Fairview patients 
using the Fairview Research Administration’s processes. Within the study 
invitation letter, patients who are interested will be instructed to contact the 
DWELL Research Laboratory via either telephone or email using the information 
contained in the letter. We will also post a digital advertisement on screens 
located in Fairview clinics. This advertisement will direct interested participants to 
contact the study team using StudyFinder. 
11.2 Identification of Potential Participants:  
Courage Kenny Rehabilitation Institute (CKRI): CKRI therapists and care 
coordinators have legitimate access to stroke diagnosis information of potential 
participants during routine clinical care. The CKRI therapist and/or care 
coordinator will make the initial contact with the patient and provide the study 
flyer. The potential participant will make the first contact with the DWELL 
Laboratory research team. If the potential participant provides the CKRI therapist 
to share their contact information with the study team as described in section 
11.1, the DWELL research team will reach out to the patient. 
Community recruitment: Participants may self-refer if they become aware of the 
study through recruitment materials or word of mouth referrals. Individuals who 
self-refer will contact the study team using the information provided on study 
materials. Potential volunteers who receive a study flyer through their stroke 
support group, DWELL Lab community engagement events, or learn about the 
study on the DWELL Laboratory website, StudyFinder, or social media will self-
identify whether they meet the diagnosis criteria (stroke within the past 12 
months) by reaching out to the study team. 
Fairview Health System: We will work with the Best Practice Integrated 
Informatics Core (BPIC) of the Clinical and Translational Science Institute (CTSI) to 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 24 of 44 
Template Revised On: 10/28/2022 
request access to the data we require for recruitment. The data will be provided 
to us in the AHC-IE Data Shelter, which is a virtual Windows server that provides 
researchers a secure environment in which to work with clinical data. All viewing 
and manipulation of the data will take place within the Data Shelter. Inbound and 
outbound Internet traffic, installation privileges and network drives are disabled 
within the shelter to prevent unauthorized access and to ensure data is not 
extracted from the shelter. Data is stored on encrypted drives and backed up 
daily to off-site locations. Only personnel named on our IRB protocol will be given 
permission to login to the Shelter to view and analyze the requested patient data. 
Furthermore, per the policies of the AHC-IE, only authorized users who have 
completed HIPAA training and completed the AHC-IE Attestation Form regarding 
confidentiality and safeguarding of AHC-IE data will be granted access. DWELL Lab 
staff who are responsible for this process will complete the Fairview Health 
System non-employee research staff (NERS) process which will allow staff to 
further screen charts of patients identified via the recruitment list provided by 
BPIC to finalize the recruitment list. Only those remaining on this list will receive 
letters mailed from Fairview Research Administration. In addition, Fairview 
clinical staff may share study flyers with potential participants with whom they 
have a treating relationship. If a potential participant is identified, the clinical staff 
will share the study flyer and instruct the potential participant to contact the 
study team using the contact information provided on the flyer.  
11.3 Recruitment Materials:  
Study flyers: We will share electronic and hard copy study flyers with CKRI 
therapists, care coordinators, and providers who interact with potential 
volunteers. Study flyers will also be shared with local stroke support groups. 
Study invitation letters: Fairview Research Administration will mail letters to 
patients identified through the BPIC electronic health record query.  
Recruitment script: This will be followed when participants contact the DWELL 
Laboratory to learn more information about the study. 
Digital advertisement: This will be displayed on digital screens in the Fairview 
Health System 
11.4 Payment:  
Volunteers will receive up to a total of $100 via the Greenphire ClinCard over the 
duration of their participation in this study. This will be paid in $25 increments 
upon the completion of (1) Week 1 assessments, (2) Interview 1, (3) Week 8 
assessments, and (4) Interview 2. Volunteers will also be allowed to keep the 
Omron 5-Series Upper Arm blood pressure monitor that they received to use 
throughout the study ($50 value). 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 25 of 44 
Template Revised On: 10/28/2022 
Upon completion of Week 1 assessments, the study coordinator will mail the 
participant’s ClinCard and, once the volunteer confirms receipt of the card, will 
load the first study payment. At each subsequent payment timepoint, the study 
coordinator will verify that the volunteer has access to their original ClinCard and 
load the payment within 2 business days of timepoint completion. If needed, a 
new ClinCard will be mailed to the volunteer.  
12.0 Withdrawal of Participants 
12.1 
Withdrawal Circumstances: Participants are free to withdraw from participation 
in the study at any time upon request. An investigator may discontinue a participant 
from the study for the following reasons: 
• The PI and intervention therapist determines that they are 
consistently not following safety plans associated with the 
activities that are planned during intervention. An example of this 
would occur when the safety protocol that the volunteer and 
intervention therapist agreed to during the prior intervention 
session requires the participant to have their caregiver/support 
person present when they engage in an activity, and the 
participant subsequently reports that they completed the activity 
alone.  
• The volunteer is re-hospitalized for any medical reason during the 
assessment or intervention period. Depending on the 
circumstances of the re-hospitalization, the volunteer may be 
offered partial withdrawal (i.e., terminate intervention but 
complete the Week 8 assessments and/or study exit interview).  
12.2 Withdrawal Procedures: Volunteers who notify study staff verbally and/or in 
writing that they wish to withdraw from the study will be offered the choice of 
full withdrawal or partial withdrawal. Full withdrawal constitutes no further 
intervention sessions or data collection. Data that were collected prior to the date 
and time of the volunteer’s notification to study staff will be maintained under 
their study ID code for analysis. Partial withdrawal constitutes no further 
intervention sessions and agreement to be contacted for subsequent assessment 
and interview timepoints. The staff member whom the volunteer notifies will 
document the conversation in the study record, including whether the volunteer 
has elected full or partial withdrawal, and (if the staff member notified is not the 
PI) will notify the PI. If the volunteer notifies the study in writing that they wish 
for their previously collected data to be destroyed, the study team will destroy all 
previously collected data (including REDCap record, activity monitoring files, and 
audiorecorded interviews and intervention sessions) 
12.3 Termination Procedures: If the study is suspended or terminated, the study team 
will cease all research activities. The study team will immediately take the 
following steps to notify volunteers based on their status in the study: 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 26 of 44 
Template Revised On: 10/28/2022 
• Currently wearing activPAL Monitor during Week 1 or Week 8 
assessments: The study team will contact volunteers and request that 
they immediately remove the activPAL monitor and return it to the study 
team using the pre-paid envelope that is provided with each device. 
• Currently completing intervention sessions: The study team will contact 
the volunteers to notify them that the study has been terminated and that 
all scheduled intervention sessions have been cancelled. 
• Scheduled for upcoming assessment sessions (Week 1, Week 8) or 
interviews (Interview 1, Interview 2): The study team will contact the 
volunteers to notify them that the study has been terminated and that all 
scheduled assessment sessions and interviews have been cancelled. 
• Scheduled for upcoming informed consent meeting: The study team will 
contact the interested volunteer to notify them that the study has been 
terminated and that enrollment has been closed to new volunteers.  
• All data collected prior to study termination will be maintained in its 
coded form to allow data analysis. Identifiers will be destroyed and data 
will be maintained in its deidentified form after it is confirmed that the 
study is permanently closed to new enrollment. 
13.0 Risks to Participants 
13.1 Foreseeable Risks:  
• Distress or fatigue associated with clinical questionnaires, 
performance measures, interviews, or intervention performed as 
part of participation in the study: Questionnaires, performance 
measures, interviews, and intervention will be delivered by 
research assistants trained and supervised by the PI, an 
occupational therapist with more than 10 years of experience 
working with the stroke population. Participants who experience 
distress, embarrassment, or fatigue will be able to take breaks 
during testing and intervention session. If needed, testing may be 
completed in multiple short sessions. 
• Discomfort or mild skin irritation associated with the activPAL 
activity monitoring protocol: The adhesive used to adhere the 
ActivPAL monitor to the participant's thigh is a common adhesive 
used in the healthcare setting. Participants who have a history of 
skin irritation are excluded from the study. Participants will receive 
instructions to monitor their skin for signs of irritation. If skin 
irritation occurs during the study, the participant will be instructed 
to transfer the activPAL to the opposite leg and continue to 
monitor for signs of irritation. Should irritation persist, participants 
will be instructed to remove the device and alternative strategies 
for activity monitoring will be explored (e.g., alternative wearing 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 27 of 44 
Template Revised On: 10/28/2022 
schedules, use of non-adhesive strategies for maintaining device 
position).  
• Risk for injury (such as a fall-related injury) while engaging in 
daily activities planned during intervention processes: 
Intervention processes will be supervised by the PI, a licensed 
occupational therapist with more than 10 years of experience in 
stroke rehabilitation. While planning activities, participants will be 
directly prompted to identify possible safety concerns and develop 
plans to assure safety (e.g. involve support person). Activities 
planned during intervention are daily activities that stroke 
survivors encounter in daily life outside of intervention. As such, 
engaging in these activities pose minimal risk. In addition, during 
activity planning, the study interventionist will also follow a safety 
protocol that clarifies whether the presence of a support person is 
required when completing the participant’s chosen activity (see 
Appendix A). In the event of an injury associated with intervention, 
participants will be instructed to seek appropriate medical care. 
• Identification of severe depressive symptoms. During the 
assessments, we will use the Neuro-QOL Depression Short Form to 
measure depressive symptoms. This is a validated measure of 
depressive symptom load among people with stroke [62]. A raw 
score of ≥26 on this measure indicates that the participant is 
experiencing severe depressive symptoms. If the participant meets 
or exceeds this score of 26 on this measure, the study team will 
verbally discuss the results with the participant, provide the 
participant with a packet (via electronic mail) which contains 
mental health crisis support information and an education sheet 
on mental health after stroke published by the American Congress 
of Rehabilitation Medicine, and encourage the participant to 
discuss these symptoms with their primary care physician 
• Inconvenience caused by study visits and telephone calls: Study 
visits and telephone calls will be scheduled according to the 
participants’ preferences, including options for evening and 
weekend visits. We will also minimize inconvenience by using 
individual participants’ preferred forms of contact for scheduling 
and session reminders (e.g. telephone call, email, text messaging). 
• The potential for breach of confidentiality: All identifiable 
information will be stored separate from the participant's research 
data. Each participant will be assigned a unique study ID number. 
Electronic data will be stored in an encrypted and password-
protected database (REDCap) and in the UMN University Box 
Secure Storage.  

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 28 of 44 
Template Revised On: 10/28/2022 
13.2 Reproduction Risks: Not applicable 
13.3 Risks to Others: Not applicable 
14.0 Potential Benefits to Participants 
14.1 
Potential Benefits: There is potential that participants may derive benefit from 
participation in the teleABLE intervention, however there is no guarantee. 
Participants may experience improvements in sedentary behavior and health-
related quality of life. 
15.0 Statistical Considerations 
15.1 Data Analysis Plan: The purpose of this formative research is to refine our 
research and intervention protocol based on (1) qualitative analyses of 
stakeholder data and (2) descriptive analyses of process data. 
(1) Stakeholder data: Audiorecorded interviews will be transcribed and interview 
transcripts, intervention session notes, and therapist reflective logs will be 
read by two researchers who will identify codes and, subsequently, themes 
that guide research protocol refinement and intervention protocol 
refinement. Discrepancies will be resolved through discussion with a third 
researcher. 
(2) Process data: Audiorecorded intervention sessions will be rated against the 
teleABLE Intervention Checklist by an independent assessor to indicate the 
presence or absence of the intervention components in each session. Study 
documentation related to attendance (sessions/week) and safety (adverse 
event count), and participant rating of satisfaction (Client Satisfaction 
Questionnaire-8) will also be computed. Descriptive process data will be 
compared against pre-established benchmarks. 
15.2 Power Analysis: Because the focus of this research is to refine our research and 
intervention protocol, the sample size was selected based on the data required to 
inform these protocols rather than tests of statistical significance. All volunteers 
will complete assessments at 2 time points, 12 intervention sessions, and 2 
interviews. Once data are collected from 5 volunteers (60 intervention sessions, 
10 interviews), thematic analyses will be initiated. Additional volunteers will be 
recruited as needed to achieve thematic saturation. We anticipate achieving 
thematic saturation with 5-10 participants (60-120 intervention sessions, 10-20 
interviews).  
15.3 Statistical Analysis: Descriptive sample statistics will be computed to describe (1) 
presence of intervention components in each session, (2) number of sessions 
attended/week, (3) adverse event count, and (4) satisfaction [Client Satisfaction 
Questionnaire-8]. These scores will be compared against pre-established 
benchmarks for (1) intervention components present in ≥90% of sessions, (2) 1.5 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 29 of 44 
Template Revised On: 10/28/2022 
to 2.5 sessions attended/week, (3) ≤ 1 adverse event, and (4) mean Client 
Satisfaction Questionnaire-8 score ≥3.  
15.4 Data Integrity: Data will be collected and monitored using strategies to assure 
data integrity.  
Data collection: Questionnaire-based data and interviews will be collected over 
synchronous videoconferencing where the volunteer provides verbal response 
and the assessor directly enters the response into REDCap (questionnaires) or 
audiorecords (interviews). At the end of the assessment or interview session, the 
assessor will complete a checklist to confirm that all questionnaires and 
interviews were completed, and that the interview was uploaded to the 
appropriate secure folder. Reasons for missing data will be documented. 
Instructions for activPAL monitoring will also be provided during the assessment 
session, and the assessor will follow up with the participant via telephone within 
48 hours to confirm that the monitor was donned appropriately. Intervention 
documentation will be entered by the treating therapist in REDCap as soon as 
possible following session completion, with the expectation that session 
documentation will be completed within 48 hours. 
Data monitoring: The PI will meet with the study team on a weekly basis to 
review the status of the study. This will include reviewing the results of (1) chart 
audits of study records of completed volunteers to assure completeness of data 
and contemporary documentation of reasons for missingness, (2) data reports 
from baseline and post-intervention timepoints to identify and resolve data entry 
errors (e.g., scores outside of possible range), and (3) monitor current volunteer 
status in study including an opportunity for the assessor and/or interventionist to 
identify problems and solutions that may have occurred during data collection. 
16.0 Health Information and Privacy Compliance 
 
16.1 
Select which of the following is applicable to your research: 
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
 
☒ I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research: N/A 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 30 of 44 
Template Revised On: 10/28/2022 
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the 
U of M stand-alone HIPAA Authorization.  Note: External IRB must be serving 
as the privacy board for this option. 
 
16.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☒ I will use the Informatics Consulting Services (ICS) available through CTSI 
(also referred to as the University's Information Exchange (IE) or data 
shelter) to pull records for me 
☒ I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe: N/A 
 
16.3 
Explain how you will ensure that only records of patients who have agreed to 
have their information used for research will be reviewed. 
PHI data will only be collected directly from volunteers who have provided 
informed consent to participate in the study. Data retrieved from the 
Informatics Consulting Service through the CTSI for recruitment will be filtered 
by Informatics Consulting Service staff to include only those patients who have 
agreed to have their information used for research. However, providers who 
have a treating relationship with the patient may discuss research opportunities 
during a clinical encounter regardless of research opt-out status and opt-out 
status will not matter if a participant contacts us first. 
16.4 
Approximate number of records required for review: 3,700 
16.5 
Please describe how you will communicate with research participants during 
the course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication 
with research participants. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 31 of 44 
Template Revised On: 10/28/2022 
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
☒ Communication with research participants will take place outside of 
treatment settings. If this box is selected, please describe the type of 
communication and how it will be received by participants.  
Throughout the course of the study, communication with research volunteers 
will occur via mail, telephone calls, videoconferencing, and if requested by 
the volunteers to minimize burden, text messages and/or emails.  
Mail: The study team will mail paper copies of the informed consent document, 
study materials (workbook, activity monitoring supplies), and study 
remuneration materials (ClinCard).  
Telephone calls: The study team will use telephone calls for the purposes of 
scheduling study visits, appointment reminders, study screening, and general 
study communications as needed. 
Videoconferencing: The study team will use the University of Minnesota Health 
Care Component Zoom account to interact with participants on their own 
devices to complete study assessments, interviews, and intervention 
sessions. 
Text messages: The study team will use text messages on a limited basis for the 
purpose of sending appointment reminders and scheduling. Text messages 
will only be used if the participant specifically requests method of 
communication. 
Emails: The study team will use email on a limited basis for the purpose of 
sending blank informed consent documents in preparation for the study 
consent meeting and sending appointment reminders. No PHI will be sent 
using email. Email will only be used if the participant specifically requests to 
receive materials and/or appointment reminders using this modality. We are 
requesting a waiver of the use of encrypted email to send study appointment 
reminders and blank informed consent documents 
16.6 
Explain how the research team has legitimate access to patients/potential 
participants: 
The research team will not access medical records of enrolled volunteers. 
Private information about volunteers who are enrolled in the study will be 
collected by study staff directly from the volunteers themselves. Because the 
volunteers have enrolled in the study, signed a HIPAA authorization form at 
the time of informed consent and are willingly providing the information as 
approved by the IRB, the study team has legitimate access to these data. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 32 of 44 
Template Revised On: 10/28/2022 
16.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☒ In the data shelter of the Information Exchange (IE)  
 ☒ Store 
☒ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☒ In REDCap (recap.ahc.umn.edu)  
 ☒ Store 
☒ Analyze 
☒ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share  
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☒ In the University’s Box Secure Storage (box.umn.edu) 
 ☒ Store 
☒ Analyze 
☒ Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
 ☐ Store 
☐ Analyze 
☐ Share 
☐☒ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: We are working with HST IT to 
establish access to a remote HST/Citrix desktop which will be used to store, 
access, and analyze identifiable data through REDCap and Box.  
 ☐☒ Store 
☐☒ Analyze ☐ Share 
☐ Other. Describe:  
Describe in detail the location and whether the data / specimens will be stored, 
analyzed, or shared, and in what ways. 
Indicate if data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet 
computer such as an iPad or a smartform (iPhone or Android devices) that you 
have not already identified in the preceding questions 
☐ I will use a server not previously listed to collect/download research data 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 33 of 44 
Template Revised On: 10/28/2022 
☒ I will use a desktop or laptop not previously listed: Research staff will use 
university-owned DWELL Laboratory laptops supported by the College of 
Education and Human Development IT team to analyze deidentified data using 
local programs (e.g., SPSS, R, NVivo, PalTechnologies). Deidentified datasets and 
output from analyses will be stored on BOX. 
☐ I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
 
16.8 Consultants. Vendors. Third Parties.  
BrightOutcome: The electronic version of the Activity Card Sort (ACS3) is 
completed using an online system managed by BrightOutcome (Buffalo Grove, IL, 
USA). The data collected using this system will only be identified using the study 
ID code. No direct identifiers will be entered. The ACS3 is encrypted using AES-
256-CBC. Data will be exported from BrightOutcome via .csv files and stored in 
the University of Minnesota Box Secure folder.  
PalTechnologies: Data collected using the activPAL monitors will be processed 
and data visualizations will be created using PalAnalysis (PalTechnologies, 
Glasgow, Scotland). The data collected using activPAL monitors will only be 
identified using the study ID code. No direct identifiers will be entered. This 
software is downloaded and runs locally using a university-owned computer. 
16.9 Links to identifiable data: Numeric study codes will be assigned by the research 
team sequentially upon volunteer enrollment into the study. The only place 
where the volunteer’s name and number will be linked are the linking file stored 
in the REDCap database. All fields on the linking file form will be marked as 
identifiers. The linking file form will be deleted from the REDCap database by the 
PI after the study is completed and the federal requirements for record retention 
has lapsed.  
16.10 Sharing of Data with Research Team Members. Research team members will be 
granted access to the REDCap database, BrightOutcome portal, and/or shared 
University of Minnesota Secure Box folder based on the data that they require 
to complete their role in the study. Team members will only access these files 
and portals from a university-owned laboratory device 
16.11 Storage of Documents: Paper documents generated as a result of this research 
project will be stored in a locked filing cabinet in Dr. Kringle’s private locked 
office in the School of Kinesiology (located at Cooke Hall). Electronic documents 
generated as a result of this research project will be stored on the University of 
Minnesota Secure Box folder and on DWELL Laboratory devices.  

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 34 of 44 
Template Revised On: 10/28/2022 
16.12 Disposal of Documents: All data will be retained for a minimum of 3 years, in 
alignment with the NIH retention policy. After 3 years, the linking file will be 
destroyed as described in section 16.9. Deidentified data and audiorecordings 
of interviews and intervention sessions will be retained on the University of 
Minnesota Secure Box folder in perpetuity to allow for secondary analyses of 
the data and to support future laboratory staff training to the intervention 
protocol. 
17.0 Confidentiality 
17.1 Data Security: Data collected electronically will be stored in the University of 
Minnesota Box Secure Storage and REDCap. These data will be accessed using 
University-owned password-protected computers and access to research data 
stored in these systems will be provided to trained study staff who require access 
to data relevant to their role on the study. All data will be stored using a study ID 
code, and the only place where the participant’s name and study ID code are 
linked will be in the REDCap linking form. All fields in the REDCap linking form will 
be marked as identifiers to prevent the export of identifiers. Paper 
documentation generated as a result of this study will be stored in a locked file 
cabinet in the locked DWELL Research Laboratory in the School of Kinesiology. 
Informed consent will be completed electronically and completed consent 
documents will be stored in a REDCap project separate from the participant’s 
study data. A copy of the consent form will not be placed in the participant’s 
medical record. Only study staff who require access to electronic or paper files 
will be granted access. These staff will be required to complete HIPAA, ISP, and 
CITI training modules on Good Clinical Practice prior to receiving access to these 
data. This is an NIH-funded study, and therefore all data are protected under a 
certificate of confidentiality. 
17.2 Data Sharing: There are no current plans for data sharing. Upon completion of the 
study, a master de-identified dataset will be created and stored in the study BOX 
site. This dataset will include questionnaire data, raw and processed activPAL 
data, and transcribed interview data. Upon request for data sharing, the PI will 
follow procedures to establish a data use agreement that provides only the 
necessary data from the master de-identified dataset. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
18.1 Data Integrity Monitoring. Data integrity will be monitored by the PI, who has 
over 10 years of experience working with people with stroke-related disability in 
clinical (as an occupational therapist) and research settings. The following 
strategies will be applied: 
1. The study team will notify the PI of new study enrollments and the PI will 
review the screening documentation form within 2 business days to 
confirm eligibility to proceed with the informed consent meeting. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 35 of 44 
Template Revised On: 10/28/2022 
2. Procedural checklists will be reviewed for completeness following each 
study visit by the study staff responsible for each visit. Reasons for 
missing data will be documented in REDCap. 
3. The PI will hold weekly meetings with the study team to review study 
enrollment, monitor volunteer progression through study procedures, 
review case report forms, and monitor adverse events. Meetings will be 
documented and meeting minutes will be stored electronically with the 
study files in the University of Minnesota Box Secure Storage. 
18.2 Data Safety Monitoring. This study will be overseen by a data safety monitor 
external to the trial and institution who has expertise in neurorehabilitation trials. 
The PI will meet with the data safety monitor every 6 months to review a report 
that includes: participant accrual, adverse events data, and data completeness. 
Adverse events data will be collected at two timepoints during the study: (1) 
during the interview 1 session, and (2) during post-intervention assessments. 
Data will be collected over the telephone or Zoom using a questionnaire. Ad hoc 
reports of adverse events will also be collected by any study staff who become 
aware of an adverse event during any study interaction. Whomever first identifies 
the adverse event will complete an ad hoc form and notify the PI who will 
determine appropriate follow-up actions and reporting. 
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy: Participants’ privacy will be protected throughout all 
interactions with the study team and in the handling of data. 
Study interactions: All study visits will take place using the University of 
Minnesota Health Care Component Zoom portal, which is HIPAA-compliant. 
Participants will be encouraged to access Zoom from a private space of their 
choosing with no others present. If they prefer, they may use headphones to 
enhance privacy. Study staff will interact with participants from a private space in 
the School of Kinesiology or a room in their home with no other people present 
and a closed door (if working remotely). If not on campus, study staff will access 
Zoom using a private/secure internet connection. Before each assessment session 
and interview, participants will be reminded that they are not required to answer 
the questions posed, and that they may tell the study staff that they do not wish 
to answer particular question/s at any time during the session. 
Data handling: All data collected from participants will be entered into the study 
database, approved web applications (REDCap, BrightOutcome), or saved to the 
University of Minnesota Secure BOX storage using university-owned computers. 
Data will be stored using the study ID code rather than participants’ names. Only 
study staff who require access to the data to complete their study-related tasks 
will be granted access to the data. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 36 of 44 
Template Revised On: 10/28/2022 
19.2 Access to Participants: All data will be provided to the research team by the study 
participants. Participants will be fully informed of the ways in which their data 
will/may be used during the informed consent process. The research team has 
been trained in conducting these conversations and the participants are also 
assessed for their understanding of consent prior to initiating any study 
procedures. 
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury: In the event that research-related 
activities result in an injury, treatment will be provided to the participant (e.g., 
first aid, emergency treatment, and follow-up care as needed). Care for such 
injuries will be billed in the ordinary manner to the participant or the participant’s 
insurance company. 
20.2 Contract Language: N/A 
21.0 Consent Process 
21.1 Consent Process (when consent will be obtained): Informed consent will occur in 
a phased manner throughout (1) telephone screening, and (2) study enrollment, 
(3) ongoing consent. 
1. Telephone screening: Participants who contact the DWELL Laboratory 
to express interest in participating in the study will provide verbal 
informed consent prior to completing the screening questions. 
Consent to complete telephone screening will be obtained by study 
staff who are trained and supervised by the PI. During the telephone 
screening call, participants will receive general information on the 
study procedures, detailed information on the telephone screening 
process, including their right to decide not to participate, and be 
informed of the risks associated with completing the telephone 
interview (i.e., breach of confidentiality, mild distress related to 
questions). Screening questions will be asked only after the potential 
participant has received this information, been offered an opportunity 
to ask questions, and verbally indicated that they would like to 
complete the telephone screening process. We are requesting a 
waiver of documentation of informed consent for this screening 
process (see below).  
2. Study enrollment: Participants who are deemed eligible to participate 
in the study based on the telephone screening will be scheduled for a 
Zoom meeting with a study staff member who is trained and 
supervised by the PI. The potential participant will be encouraged to 
invite a support person to this meeting, and to join the meeting from a 
location where they will be comfortable discussing their possible 
participation in the study. Prior to the meeting, a blank copy of the 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 37 of 44 
Template Revised On: 10/28/2022 
consent form will be sent to the potential participant in either hard 
copy or electronic format (based on the potential participant’s 
preference). This form will contain the combined HIPAA 
Authorization/Consent document (HRP-593). During this meeting, the 
study staff member will review the informed consent document and 
provide opportunities for the potential participant and their support 
person to ask questions. Questions will be actively invited, and once all 
questions have been answered, the study staff will provide time for 
the potential participant and their support person to discuss their 
decision without study staff present (i.e. Zoom camera and 
microphone muted). If the potential participant decides to provide 
informed consent, the study staff will ask the potential participant 3 
teach-back questions: (1) what are they being asked to do if they agree 
to participate in the study, (2) what risks are associated with the study, 
and (3) if they decide they no longer wish to participate in the study, 
how would they go about withdrawing. After the potential participant 
has responded to these questions accurately, the study staff will send 
a survey link to the eConsent form to allow the potential participant to 
sign electronically via REDCap. 
3. Ongoing consent: At the beginning of each study visit, the study staff 
who are leading the visit will explain the purpose of the visit, the 
estimated time that the visit will require, and obtain verbal 
affirmation/permission from participant regarding their willingness to 
complete the study visit 
21.2 Waiver or Alteration of Consent Process (when consent will not be obtained): N/A 
21.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained):  
We are requesting a waiver of written informed consent to screen interested 
potential participants over the telephone. The telephone screening poses no 
more than minimal risk. Participants will respond to questions related to their 
age, stroke diagnosis, mobility status, daily activities, depressive symptoms, and 
medical comorbidities. In addition, it is impractical to ask people who have 
stroke-related disability to travel to the university to complete written consent 
for a 15-minute questionnaire for the purpose of determining their eligibility. The 
telephone screening will be conducted by a member of the research team 
supervised by Dr. Kringle, who is a licensed occupational therapist with 10 years 
of clinical and research experience directly interacting with people with stroke-
related disability. During the telephone screening call, participants will receive 
general information on the study procedures, detailed information on the 
telephone screening process, including their right to decide not to participate, 
and be informed of the minimal risks associated with completing the telephone 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 38 of 44 
Template Revised On: 10/28/2022 
interview. If the participant verbally agrees to answer the screening questions, 
verbal consent will be documented electronically by the research assistant and 
the telephone screening questions will be completed.  
21.4 Non-English Speaking Participants: N/A 
21.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years 
of age): N/A 
21.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: N/A 
21.7 Adults Unable to Consent: N/A 
22.0 Setting 
22.1 Research Sites: 
1. 
The research team will primarily identify volunteers through: (1) distribution 
of flyers through the Allina Health System/Courage Kenny Rehabilitation 
Institute’s Stroke Program and community stroke support groups. We will 
also partner with Fairview Research Administration to mail study invitations 
to potential participants identified through the University of Minnesota’s 
Clinical and Translational Science Institute’s (CTSI) Clinical Data Repository 
(CDR) that is hosted by the Academic Health Center Information Exchange 
(AHC-IE).  
People who learn about the study through flyers or invitation letters and 
who are interested in participating in this study will reach out to the 
research team via email or telephone. 
2. 
All study activities will completed from the participant’s home using their 
personal device to access Zoom videoconferencing to interact with the 
study team.  
3. 
There is currently no community advisory board for this study. 
4. 
Apart from distributing recruitment flyers and study invitation letters, all 
study activities will take place in the Disability and WELLness Laboratory 
which is part of the School of Kinesiology at the University of Minnesota.  
Allina Health System/Courage Kenny Rehabilitation Institute: Following 
approval of the University of Minnesota IRB application, the approved IRB 
will be submitted to the Determination of Engagement Review Process 
during which the Allina Health System IRB will determine whether its staff 
may distribute flyers to patients in that health system. 
22.2 International Research: N/A  
23.0 Multi-Site Research 
N/A  

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 39 of 44 
Template Revised On: 10/28/2022 
24.0 Coordinating Center Research 
N/A 
24.1 Role: N/A  
24.2 Responsibilities: N/A 
24.3 Oversight: N/A  
24.4 Collection and Management of Data: N/A  
25.0 Resources Available 
25.1 Resources Available: This research is funded by an NIH K23 award (K23 
HL159240). In addition, the study has access to the following resources:  
Access to potential participants: Dr. Kringle has an established relationship with 
providers at Courage Kenny Rehabilitation Institute/Allina Health System which 
provides care to approximately 2700 stroke patients annually. In addition, 
Fairview Health System treated approximately 5000 stroke patients within the 
past year. These systems will support recruitment of 5 to 10 participants over 3 to 
6 months.  
Staff support towards this project: Dr. Kringle is supported by an NIH K23 award 
which provides 75% effort dedicated to this research. In addition, the Disability 
and WELLness (DWELL) Laboratory team, which is led by Dr. Kringle, consists of a 
research occupational therapist who has experience with the intervention under 
study and a part-time research coordinator who will dedicate 8 to 10 hours/week 
to this research.  
Study facilities and supplies: All study visits are completed remotely. The study 
team members will use university-owned devices to conduct study visits. The 
DWELL Research Team has access to private space in the School of Kinesiology 
from which study visits will be held. Study staff who are work remotely will 
identify a private work space that has a door and private/secured internet 
connection from which they will hold study visits. 
Medical or psychological resources: If a participant reports an event that requires 
medical attention, they will be advised to seek care at the healthcare facility that 
they would typically access and/or the nearest emergency medical center. If a 
participant scores ≥26 (raw score) on the NeuroQOL Depression questionnaire, 
they will be provided with information on accessing mental health resources, 
including national mental health crisis line information and an educational page 
regarding mental health after stroke published by the American Congress of 
Rehabilitation Medicine and which contains additional information on accessing 
mental health resources. 
Study personnel orientation: All personnel who are assisting with this research 
will complete a study onboarding process led by Dr. Kringle that includes a broad 
overview of the study protocol (including access to the full study protocol) and 
training to criterion in the research procedures that the individual study staff 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 40 of 44 
Template Revised On: 10/28/2022 
member is responsible for carrying out. In addition, all personnel will receive 
initial and ongoing training in the responsible conduct of research, adverse event 
identification and reporting, Good Clinical Practice, HIPAA compliance, and 
information security and data safety practices. Initial training will be guided by an 
onboarding checklist. Ongoing training will occur as part of routine laboratory 
meetings. 
26.0 References 
1. 
Tsao, C.W., et al., Heart disease and stroke statistics—2022 update: A report from the 
American Heart Association. Circulation, 2022. 145(8). 
2. 
English, C., et al., Physical activity and sedentary behaviors in people with stroke living 
in the community: A systematic review. Physical Therapy, 2014. 94(2): p. 185-196. 
3. 
Elamy, A., et al., Common comorbidities of stroke in the Canadian population. Can J 
Neurol Sci, 2020. 47(3): p. 314-319. 
4. 
González, K., J. Fuentes, and J.L. Márquez, Physical inactivity, sedentary behavior and 
chronic diseases. Korean Journal of Family Medicine, 2017. 38(3): p. 111. 
5. 
Rezende, L.F.M.D., et al., Sedentary behavior and health outcomes among older adults: 
A systematic review. BMC Public Health, 2014. 14(1): p. 333. 
6. 
Rezende, L.F.M.D., et al., Sedentary behavior and health outcomes: An overview of 
systematic reviews. PLoS ONE, 2014. 9(8): p. e105620. 
7. 
Chastin, S.F.M., et al., Meta-analysis of the relationship between breaks in sedentary 
behavior and cardiometabolic health. Obesity, 2015. 23(9): p. 1800-1810. 
8. 
Furlanetto, K.C., et al., Sedentary behavior is an independent predictor of mortality in 
subjects with COPD. Respiratory Care, 2017. 62(5): p. 579-587. 
9. 
Morton, S., et al., Sedentary behavior after stroke: A new target for therapeutic 
intervention. Int J Stroke, 2019. 14(1): p. 9-11. 
10. 
Kapoor, A., et al., “Good outcome” isn’t good enough: Cognitive impairment, 
depressive symptoms, and social restrictions in physically recovered stroke patients. 
Stroke, 2017. 48(6): p. 1688-1690. 
11. 
Débora Pacheco, B., et al., Perceived barriers to exercise reported by individuals with 
stroke, who are able to walk in the community. Disability and Rehabilitation, 2021. 
43(3): p. 331-337. 
12. 
De Rooij, I.J.M., et al., Perceived barriers and facilitators for gait-related participation 
in people after stroke: From a patients’ perspective. Physiotherapy Theory and Practice, 
2021. 37(12): p. 1337-1345. 
13. 
Nicholson, S., et al., A systematic review of perceived barriers and motivators to 
physical activity after stroke. International Journal of Stroke, 2013. 8(5): p. 357-364. 
14. 
Rimmer, J.H., E. Wang, and D. Smith, Barriers associated with exercise and community 
access for individuals with stroke. Journal of Rehabilitation Research & Development, 
2008. 45(2). 
15. 
Damush, T.M., et al., Barriers and facilitators to exercise among stroke survivors. 
Rehabilitation Nursing, 2007. 32(6): p. 253-260. 
16. 
Kringle, E.A., et al., Development and feasibility of a sedentary behavior intervention 
for stroke: A case series. Topics in Stroke Rehabilitation, 2019. 26(6): p. 456-463. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 41 of 44 
Template Revised On: 10/28/2022 
17. 
Kringle, E.A., et al., Activating behavior to reduce sedentary behavior after stroke: A 
nonrandomized pilot feasibility study. American Journal of Occupational Therapy, 2020. 
74(6): p. 7406205030p1-7406205030p10. 
18. 
Prince, S.A., et al., A comparison of the effectiveness of physical activity and sedentary 
behaviour interventions in reducing sedentary time in adults: A systematic review and 
meta‐analysis of controlled trials. Obesity Reviews, 2014. 15(11): p. 905-919. 
19. 
Kringle, E.A., et al., Influence of interventions on daily physical activity and sedentary 
behavior after stroke: A systematic review. PM& R, 2020. 12(2): p. 186-201. 
20. 
English, C., et al., Reducing sitting time after stroke: A phase II safety and feasibility 
randomized controlled trial. Archives of Physical Medicine and Rehabilitation, 2016. 
97(2): p. 273-280. 
21. 
Ezeugwu, V.E. and P.J. Manns, The feasibility and longitudinal effects of a home-based 
sedentary behavior change intervention after stroke. Archives of Physical Medicine and 
Rehabilitation, 2018. 99(12): p. 2540-2547. 
22. 
Moore, S.A., et al., Physical activity, sedentary behaviour and metabolic control 
following stroke: A cross-sectional and longitudinal study. PLoS ONE, 2013. 8(1): p. 
e55263. 
23. 
Mahendran, N., S.S. Kuys, and S.G. Brauer, Recovery of ambulation activity across the 
first six months post-stroke. Gait & Posture, 2016. 49: p. 271-276. 
24. 
Tieges, Z., et al., Sedentary behavior in the first year after stroke: A longitudinal cohort 
study with objective measures. Archives of Physical Medicine and Rehabilitation, 2015. 
96(1): p. 15-23. 
25. 
Lawrence, M., et al., Stroke survivors’ and family members’ perspectives of multimodal 
lifestyle interventions for secondary prevention of stroke and transient ischemic attack: 
a qualitative review and meta-aggregation. Disability and Rehabilitation, 2016. 38(1): p. 
11-21. 
26. 
Townend, E., et al., Fear of recurrence and beliefs about preventing recurrence in 
persons who have suffered a stroke. Journal of Psychosomatic Research, 2006. 61(6): p. 
747-755. 
27. 
Chang, M.C. and M. Boudier-Revéret, Usefulness of telerehabilitation for stroke 
patients during the COVID-19 pandemic. American Journal of Physical Medicine & 
Rehabilitation, 2020. 99(7): p. 582. 
28. 
Tenforde, A.S., et al., Outpatient physical, occupational, and speech therapy 
synchronous telemedicine: a survey study of patient satisfaction with virtual visits 
during the COVID-19 pandemic. American Journal of Physical Medicine & 
Rehabilitation, 2020. 99(11): p. 977-981. 
29. 
Tenforde, A.S., et al., Evidence-based physiatry: efficacy of home-based 
telerehabilitation versus in-clinic therapy for adults after stroke. American Journal of 
Physical Medicine & Rehabilitation, 2020. 99(8): p. 764-765. 
30. 
Sarfo, F.S., et al., Tele-rehabilitation after stroke: An updated systematic review of the 
literature. Journal of Stroke and Cerebrovascular Diseases, 2018. 27(9): p. 2306-2318. 
31. 
Sarsak, H.I., Telerehabilitation services: A successful paradigm for occupational 
therapy clinical services. Int Phys Med Rehabil J, 2020. 5(2): p. 93-98. 
32. 
Laver, K.E., et al., Telerehabilitation services for stroke. Cochrane Database of 
Systematic Reviews, 2020. 2020(1). 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 42 of 44 
Template Revised On: 10/28/2022 
33. 
Tchero, H., et al., Telerehabilitation for stroke survivors: Systematic review and meta-
analysis. Journal of Medical Internet Research, 2018. 20(10): p. e10867. 
34. 
Compernolle, S., et al., Effectiveness of interventions using self-monitoring to reduce 
sedentary behavior in adults: a systematic review and meta-analysis. International 
Journal of Behavioral Nutrition and Physical Activity, 2019. 16(1). 
35. 
Cuijpers, P., A. Van Straten, and L. Warmerdam, Behavioral activation treatments of 
depression: A meta-analysis. Clinical Psychology Review, 2007. 27(3): p. 318-326. 
36. 
Kanter, J.W., et al., What is behavioral activation?: A review of the empirical literature. 
Clinical Psychology Review, 2010. 30(6): p. 608-620. 
37. 
Dorman, P., et al., Qualitative comparison of the reliability of health status assessments 
with the EuroQol and SF-36 questionnaires after stroke. Stroke, 1998. 29(1): p. 63-68. 
38. 
Dorman, P.J., et al., Is the EuroQol a valid measure of health-related quality of life after 
stroke? Stroke, 1997. 28(10): p. 1876-1882. 
39. 
Katz, N., et al., Participation in occupational performance: Reliability and validity of 
the Activity Card Sort. OTJR: Occupation, Participation and Health, 2003. 23(1): p. 10-
17. 
40. 
Bond, F.W., et al., Preliminary psychometric properties of the Acceptance and Action 
Questionnaire–II: A revised measure of psychological inflexibility and experiential 
avoidance. Behavior Therapy, 2011. 42(4): p. 676-688. 
41. 
Lachman, M.E., et al., Fear of falling and activity restriction: the survey of activities 
and fear of falling in the elderly (SAFE). The Journals of Gerontology Series B: 
Psychological Sciences and Social Sciences, 1998. 53(1): p. P43-P50. 
42. 
Liu, T.-W. and S.S.M. Ng, The reliability and validity of the Survey of Activities and 
Fear of Falling in the Elderly for assessing fear and activity avoidance among stroke 
survivors. PLOS ONE, 2019. 14(4): p. e0214796. 
43. 
Dreer, L.E., et al., Efficient assessment of social problem-solving abilities in medical 
and rehabilitation settings: a rasch analysis of the social problem-solving inventory-
revised. Journal of Clinical Psychology, 2009. 65(7): p. 653-669. 
44. 
Schwarzer, R. and M. Jerusalem, Generalized self-efficacy scale, in Measures in health 
psychology: A user’s portfolio. Causal and control beliefs, S.W. J. Weinman, & M. 
Johnston, Editor. 1995. p. 37. 
45. 
Attkisson, C.C. and T.K. Greenfield, The UCSF Client Satisfaction Scales: I. The Client 
Satisfaction Questionnaire-8, in The use of psychological testing for treatment planning 
and outcomes assessment: Instruments for adults. 2004, Lawrence Erlbaum Associates 
Publishers: Mahwah, NJ, US. p. 799-811. 
46. 
Sangha, O., et al., The Self-Administered Comorbidity Questionnaire: A new method to 
assess comorbidity for clinical and health services research. Arthritis & Rheumatism, 
2003. 49(2): p. 156-163. 
47. 
Cella, D., et al., Neuro-QOL: Brief measures of health-related quality of life for clinical 
research in neurology. Neurology, 2012. 78(23): p. 1860-1867. 
48. 
Mong, Y., T. Teo, and S.S. Ng, 5-repetition sit-to-stand test in subjects with chronic 
stroke: Reliability and validity. Arch Phys Med Rehabil, 2010. 91: p. 407-413. 
49. 
Jones, C., R. Rikli, and W. Beam, A 30-s chair-stand test as a measure of lower body 
strength in community-residing older adults. Research Quarterly for Exercise and Sport, 
1999. 70: p. 113-119. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 43 of 44 
Template Revised On: 10/28/2022 
50. 
Wong, A., et al., Montreal Cognitive Assessment 5-Minute protocol is a brief, valid, 
reliable, and feasible cognitive screen for telephone administration. Stroke, 2015. 46(4): 
p. 1059-1064. 
51. 
Hunsley, J., et al., The seven-item short form of the Dyadic Adjustment Scale: further 
evidence for construct validity. American Journal of Family Therapy, 2001. 29(4): p. 
325-335. 
52. 
Sharpley, C.F. and H.J. Rogers, Preliminary validation of the Abbreviated Spanier 
Dyadic Adjustment Scale: Some psychometric data regarding a screening test of marital 
adjustment. Educational and Psychological Measurement, 1984. 44(4): p. 1045-1049. 
53. 
Spanier, G.B., Measuring dyadic adjustment: New scales for assessing the quality of 
marriage and similar dyads. Journal of Marriage and the Family, 1976: p. 15-28. 
54. 
Aron, A., E.N. Aron, and D. Smollan, Inclusion of Other in the Self Scale and the 
structure of interpersonal closeness. Journal of Personality and Social Psychology, 
1992. 63(4): p. 596. 
55. 
Shimbo, D., et al., Self-Measured Blood Pressure Monitoring at Home: A Joint Policy 
Statement From the American Heart Association and American Medical Association. 
Circulation, 2020. 142(4). 
56. 
Gibbs, B.B., et al., Effect of reducing sedentary behavior on blood pressure (RESET 
BP): Rationale, design, and methods. Contemporary Clinical Trials, 2021. 106428. 
57. 
Taraldsen, K., et al., Evaluation of a body-worn sensor system to measure physical 
activity in older people with impaired function. Physical Therapy, 2011. 91(2): p. 277-
285. 
58. 
Kringle, E.A., et al., Sedentary behavior patterns over 6 weeks among ambulatory 
people with stroke. Topics in Stroke Rehabilitation, 2021. 28(7): p. 537-544. 
59. 
Edwardson, C.L., et al., Considerations when using the activPAL monitor in field-based 
research with adult populations. Journal of Sport and Health Science, 2017. 6(2): p. 
162-178. 
60. 
Dowd, K.P., et al., The measurement of sedentary patterns and behaviors using the 
activPAL™ professional physical activity monitor. Physiological Measurement, 2012. 
33(11): p. 1887. 
61. 
Barone Gibbs, B. and C.E. Kline, When does sedentary behavior become sleep? A 
proposed framework for classifying activity during sleep-wake transitions. International 
Journal of Behavioral Nutrition and Physical Activity, 2018. 15(1). 
62. 
Kroenke, K., et al., Minimally important differences and severity thresholds are 
estimated for the PROMIS depression scales from three randomized clinical trials. 
Journal of Affective Disorders, 2020. 266: p. 100-108. 
63. 
Rosenberg, D.E., et al., Reliability and validity of the Sedentary Behavior Questionnaire 
(SBQ) for Adults. Journal of Physical Activity and Health, 2010. 7(6): p. 697-705. 
64. 
Ottenbacher, K.J., et al., The reliability of the functional independence measure: a 
quantitative review. Archives of Physical Medicine and Rehabilitation, 1996. 77(12): p. 
1226-1232. 
65. 
Arroll, B., et al., Validation of PHQ-2 and PHQ-9 to screen for major depression in the 
primary care population. The Annals of Family Medicine, 2010. 8(4): p. 348-353. 
66. 
Wallace, M.K., et al., Patterns of physical activity and sedentary behavior before and 
during pregnancy and cardiometabolic outcomes. Midwifery, 2022. 114: p. 103452. 

PROTOCOL TITLE: teleABLE: Adapting a Behavioral Activation-Based Intervention to 
Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) 
 
NCT05029284 
VERSION DATE: 07.21.2023 
 
Page 44 of 44 
Template Revised On: 10/28/2022