teleABLE to Reduce Post-Stroke Sedentary Behavior

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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement); Other: Health Education

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karli Jahnke, MOT, OTR/L; Phone Number: 612-626-4046; Email: dwell@umn.edu
• Study Contact Backup: Name: Emily Kringle, PhD, OTR/L; Phone Number: 612-626-4046; Email: dwell@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • School of Kinesiology, University of Minnesota
      • Contact: Karli Jahnke, MOT, OTR/L; Phone Number: 612-626-4046; Email: dwell@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Emily Kringle, PhD, OTR/L, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; rehabilitation; occupational therapy; behavioral activation; sedentary behavior; activity engagement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STUDY00021288; K23HL159240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No