teleABLE to Reduce Post-Stroke Sedentary Behavior

Stroke Clinical Trial

Official title:

teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Pilot Randomized Controlled Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312709
• Other study ID #: STUDY00021288
• Secondary ID: K23HL159240
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Karli Jahnke, MOT, OTR/L
• Phone: 612-626-4046
• Email: dwell[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: July 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• teleABLE (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.

Other:
• Health Education
Health Education provides information about stroke using factsheets from the American Heart Association and reflection questions that support participants in applying the information.

Locations

Country	Name	City	State
United States	School of Kinesiology, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Between-group difference in change in step count	Mean daily step count measured using the activPAL micro4 (7-day wear protocol)	Week 0 to Week 8
Other	Between-group difference in change in step count	Mean daily step count measured using the activPAL micro4 (7-day wear protocol)	Week 0 to Week 24
Other	Between-group difference in change in total activity retention	Change in the proportion of total activities retained measured using the Activity Card Sort (ACS3)	Week 0 to Week 8
Other	Between-group difference in change in total activity retention	Change in the proportion of total activities retained measured using the Activity Card Sort (ACS3)	Week 0 to Week 24
Primary	Between-group difference in change scores on health-related quality of life	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).	Week 0 to Week 8
Primary	Between-group difference in change in sedentary behavior	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)	Week 0 to Week 8
Secondary	Between-group difference in change in sedentary behavior	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)	Week 0 to Week 24
Secondary	Between-group difference in change scores on health-related quality of life	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).	Week 0 to Week 24