Clinical trial NCT06312709: teleABLE to Reduce Post-Stroke Sedentary Behavior
Official title: teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Pilot Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: sedentary behavior
physical activity
behavioral activation
activity engagement
occupational therapy
rehabilitation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-03-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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
* Concurrent participation in any other rehabilitation intervention research study (including cognitive and/or physical rehabilitation studies)
* Investigator discretion for safety or adherence reasons

Primary outcomes:
measure: Between-group difference in change scores on health-related quality of life
timeFrame: Week 0 to Week 8
measure: Between-group difference in change in sedentary behavior
timeFrame: Week 0 to Week 8
Secondary outcomes:
measure: Between-group difference in change in sedentary behavior
timeFrame: Week 0 to Week 24
measure: Between-group difference in change scores on health-related quality of life
timeFrame: Week 0 to Week 24
Other outcomes:
measure: Between-group difference in change in step count
timeFrame: Week 0 to Week 8
measure: Between-group difference in change in step count
timeFrame: Week 0 to Week 24
measure: Between-group difference in change in total activity retention
timeFrame: Week 0 to Week 8
measure: Between-group difference in change in total activity retention
timeFrame: Week 0 to Week 24
Locations:
city: Minneapolis
country: United States
facility: School of Kinesiology, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Emily Kringle, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: