teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Pilot Randomized Controlled Trial)
Overview
- Phase
- Not Applicable
- Intervention
- teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)
- Conditions
- Stroke
- Sponsor
- University of Minnesota
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Between-group difference in change in sedentary behavior
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
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
Investigators
Eligibility Criteria
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)
- •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
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)
- •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
Arms & Interventions
teleABLE
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.
Intervention: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)
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.
Intervention: Health Education
Outcomes
Primary Outcomes
Between-group difference in change in sedentary behavior
Time Frame: 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
Time Frame: 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 Outcomes
- Between-group difference in change in sedentary behavior(Week 0 to Week 24)
- Between-group difference in change scores on health-related quality of life(Week 0 to Week 24)