Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth

Study Overview
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Brief Summary
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Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time. The purpose of this research is to test whether the teleABLE (Activating Behavior for Lasting Engagement) Intervention is feasible and acceptable to adults within the first 12 months post-stroke. The hypothesis is that teleABLE can be feasibly delivered using videoconferencing within the first 12 months post-stroke. 10 participants will complete assessments and activity monitoring (activPAL micro3) at 0 (baseline) and 8 (post-intervention)-weeks. Participants will complete 12 sessions of the teleABLE intervention. Findings from this study will be used to guide the intervention protocol in the planned next phase of this research.

Official Title
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teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase)

Conditions
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Stroke Hemorrhagic, Stroke, Stroke, Ischemic

Intervention / Treatment
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* Behavioral: teleABLE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke diagnosis ≤12 months prior to study enrollment ≥6 hours of sedentary behavior on a typical weekday (assessed by Sedentary Behavior Questionnaire) Ambulatory with or without assistive device (assessed by Functional Independence Measure, mobility score ≥5) 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 the participant has face-to-face interaction at least one time per week Able and willing to participate fully in the study and provide informed consent 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 (assessed by Patient Health Questionnaire-2, score ≥2) 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 in hospice care 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 another rehabilitation intervention research study Investigator discretion for safety or adherence reasons

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: teleABLE<br>Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. | Behavioral: teleABLE<br>* Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | The count of treatment-related serious (e.g. injurious) and non-serious (e.g. fall without injury) adverse events that occur during intervention delivery will be reported. | week 2 through week 7 | 
| Participant Satisfaction | Assessed by the Client Satisfaction Questionnaire-8. This is an 8-item questionnaire with each item ranked on an 1 to 4 Likert-type scale. We will compute the mean score across all items. The possible range is 1 to 4, with high scores indicating high satisfaction. | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Participation Restrictions | Assessed by the Activity Card Sort 3. This is a 100-item tool during which participants indicate whether they did the activity prior to their stroke, continue to do the activity since their stroke, or have given up the activity since their stroke. Change in the proportion of activities retained will be reported. | week 0 to week 8 | 
| Change in Health-Related Quality of Life | Assessed by the EuroQol-5 Dimension-5 Level. This is a 5-item self-report questionnaire with each item scored on a 1 to 5 scale. Scores are converted to Index Scores following published procedures (possible range -0.573 to 1), with high scores indicating high quality of life. | week 0 to week 8 | 
| Change in Sedentary Minutes | Assessed using the activPAL micro3 monitor following a 7-day wear protocol. The mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be computed for each time point. Change in mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be reported. | week 0 to week 8 |