teleABLE to Reduce Post-Stroke Sedentary Behavior

University of Minnesota (UMN)

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement); Other: Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06312709

STUDY00021288

K23HL159240 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

teleABLE

Experimental group

Description:

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.

Treatment:

Behavioral: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)

Health Education

Active Comparator group

Description:

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.

Treatment:

Other: Health Education