Stroke
Conditions
Keywords
sedentary behavior, physical activity, behavioral activation, activity engagement, occupational therapy, rehabilitation
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
Interventions
BEHAVIORALteleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)
teleABLE uses behavioral activation to build personally meaningful non-sedentary throughout the day. This is accomplished using a global strategy, the ICAN Planning Process, which guides participants through activity scheduling, activity monitoring, self-assessment, and collaborative problem solving.
OTHERHealth Education
Health Education provides information about stroke using factsheets from the American Heart Association and reflection questions that support participants in applying the information.
Sponsors
University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Concurrent participation in any other rehabilitation intervention research study (including cognitive and/or physical rehabilitation studies) * Investigator discretion for safety or adherence reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily Kringle, PhD, OTR/L
University of Minnesota
Outcome results
None listed