duoABLE for People With Stroke and Their Caregivers

Study Overview
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Brief Summary
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The goal of this intervention study is to test whether a behavioral program that involves people with stroke and their caregivers is acceptable, safe, and can promote physically active lifestyles using enjoyable activities. Participant duos (person with stroke and their caregiver) will be asked to complete assessments at 2 timepoints, wear an activity tracker, participate in 12 sessions with an occupational therapist, and complete an interview.

Official Title
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duoABLE for People With Stroke and Their Caregivers (Feasibility)

Conditions
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Stroke, Stroke Ischemic, Stroke Hemorrhagic, Stroke Sequelae

Intervention / Treatment
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* Behavioral: duoABLE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Stroke Participants): Stroke diagnosed more than 6 months ago Are 18 years of age or older Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week Reside in a community-based setting Are mobile within their home, with or without an assistive device and without physical assistance Are able to identify an eligible caregiver who will engage in assessments and intervention. Inclusion Criteria (Caregiver Participants): Are 18 years of age or older Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week Reside in a community-based setting Are mobile within their home, with or without an assistive device and without physical assistance Exclusion Criteria (Stroke Participants): Severe aphasia Are currently receiving chemotherapy or radiation treatments for cancer Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma) Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months Have a history of skin sensitivity related to adhesives Are pregnant or expecting to become pregnant in the next 2 months Reside in an institutional setting Are currently incarcerated Exclusion Criteria (Caregiver Participants): Have a history of skin sensitivity related to adhesives Are currently receiving chemotherapy or radiation treatments for cancer Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma) Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months Are pregnant or expecting to become pregnant in the next 2 months Reside in an institutional setting Are currently incarcerated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: duoABLE<br>Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels | Behavioral: duoABLE<br>* Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction | Measured using the Client Satisfaction Questionnaire-8 (CSQ-8) | Score at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activity restrictions | Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3 | Baseline to 8 weeks | 
| Change in sedentary minutes per day | Minutes of sedentary time per day, measured using the activPAL micro4 (mean minutes per day determined by 7-day wear protocol) at baseline and week 8. | Baseline to 8 weeks | 
| Change in daily step count | Count of steps per day, measured using the activPAL micro4 (mean daily step count determined by 7-day wear protocol) at baseline and week 8. | Baseline to 8 weeks | 
| Change in Health-related quality of life | Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8 | Baseline to 8 weeks | 
| Adverse event count | Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks | Count of adverse events at week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle, physical activity, duoABLE, ABLE, rehabilitation, rehab, occupational therapy, physical therapy, stroke