teleABLE to Reduce Post-Stroke Sedentary Behavior
- Conditions
- Stroke
- Interventions
- Behavioral: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)Other: Health Education
- Registration Number
- NCT06312709
- Lead Sponsor
- University of Minnesota
- Brief Summary
The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months.
Participants in this study will:
* Complete questionnaires at Weeks 1, 8, and 24
* Wear an activPAL monitor at Weeks 1, 8, and 24
* Participate in the teleABLE intervention (12 sessions) or the health education intervention (6 sessions)
* Complete an interview at Week 24
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
- 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)
- Able to walk 150 feet or more without physical assistance from another person, 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 they have a face-to-face interaction at least one time per week.
- Able and willing to participate fully in the study and provide informed consent
- 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)
- 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 6 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description teleABLE teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement) Participants meet with a study therapist 2x/week for 6 weeks (12 sessions) to complete behavioral activation focused on adding personally meaningful non-sedentary activities during times when they typically spend sitting. All sessions are delivered remotely using Zoom videoconferencing. Health Education Health Education Participants meet with a study therapist 1x/week for 6 weeks (6 sessions) to review fact sheets focused on healthy lifestyles after stroke. All sessions are delivered remotely using Zoom videoconferencing.
- Primary Outcome Measures
Name Time Method Between-group difference in change in sedentary behavior Week 0 to Week 8 Change in mean minutes per day spent in prolonged sedentary time (accumulated in bouts of 30 minutes or more) measured using the activPAL micro4 (7-day wear protocol)
Between-group difference in change scores on health-related quality of life Week 0 to Week 8 European Quality of Life 5-Dimension 5-Level (EuroQOL-5D-5L) change score. The possible range on this tool is -1 (worst) to 1 (best).
- Secondary Outcome Measures
Name Time Method Between-group difference in change in sedentary behavior Week 0 to Week 24 Change in mean minutes per day spent in prolonged sedentary time (accumulated in bouts of 30 minutes or more) measured using the activPAL micro4 (7-day wear protocol)
Between-group difference in change scores on health-related quality of life Week 0 to Week 24 European Quality of Life 5-Dimension 5-Level (EuroQOL-5D-5L) change score. The possible range on this tool is -1 (worst) to 1 (best).
Trial Locations
- Locations (1)
School of Kinesiology, University of Minnesota
🇺🇸Minneapolis, Minnesota, United States