Using telehealth to reduce sitting time after stroke
teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Pilot Randomized Controlled Trial)
This study is testing a new online program called 'teleABLE' to see if it can help stroke survivors move more and feel better compared to a regular health education program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06312709 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests a remote behavioral activation intervention called 'teleABLE' to see if it is more effective than a health education program in reducing sedentary behavior and improving health-related quality of life in adults who have had a stroke within the past year. Participants will engage in 12 sessions of the teleABLE intervention or 6 sessions of health education, complete questionnaires, and wear an activity monitor to track their progress. The study aims to assess the impact of these interventions over a 24-week period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke within the last 12 months and exhibit high levels of sedentary behavior.
Not a fit: Patients currently in inpatient rehabilitation or with severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for stroke survivors by promoting increased physical activity and reducing sedentary behavior.
How similar studies have performed: Other studies have shown promising results with telehealth interventions aimed at increasing physical activity among stroke survivors, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 * Concurrent participation in any other rehabilitation intervention research study (including cognitive and/or physical rehabilitation studies) * Investigator discretion for safety or adherence reasons
Where this trial is running
Minneapolis, Minnesota
- School of Kinesiology, University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Emily Kringle, PhD, OTR/L — University of Minnesota
- Study coordinator: Karli Jahnke, MOT, OTR/L
- Email: dwell@umn.edu
- Phone: 612-626-4046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.