teleABLE to Reduce Post-Stroke Sedentary Behavior

NCT ID: NCT06312709

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2026-07-31

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

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

teleABLE

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.

Group Type: EXPERIMENTAL

teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement)

Intervention Type: BEHAVIORAL

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.

Health Education

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.

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Kringle, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

School of Kinesiology, University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karli Jahnke, MOT, OTR/L

Role: CONTACT

dwell@umn.edu

612-626-4046

Emily Kringle, PhD, OTR/L

Role: CONTACT

dwell@umn.edu

612-626-4046

Facility Contacts

Karli Jahnke, MOT, OTR/L

Role: primary

dwell@umn.edu

612-626-4046

Other Identifiers

K23HL159240

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00021288

Identifier Type: -

Identifier Source: org_study_id