RECRUITING

teleABLE to Reduce Post-Stroke Sedentary Behavior

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-04-04
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06312709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 18 years or older
  2. * Diagnosis: Stroke diagnosis ≤12 months prior to study enrollment
  3. * ≥6 hours of sedentary behavior on a typical weekday (Sedentary Behavior Questionnaire)
  4. * 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)
  5. * Able to access an electronic device (smartphone, tablet, or computer) that is compatible with a videoconferencing application
  6. * Able to identify a support person with whom they have a face-to-face interaction at least one time per week.
  7. * Able and willing to participate fully in the study and provide informed consent
  1. * Currently receiving care in an inpatient rehabilitation, transitional care unit, or skilled nursing facility
  2. * Severe cognitive or communication impairments (inability to respond accurately to complete study telephone screening or complete informed consent)
  3. * Comorbid neurodegenerative disorder (e.g. Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma)
  4. * Comorbid cancer, currently undergoing chemotherapy or radiation treatment
  5. * Comorbid major depressive disorder (Patient Health Questionnaire-2, score ≥2)
  6. * Received inpatient treatment or hospitalized for psychiatric condition and/or alcohol or substance abuse within the past 12 months
  7. * Diagnosis of a terminal illness and/or currently receiving hospice care
  8. * Currently pregnant or expecting to become pregnant in the next 6 months
  9. * History of skin sensitivity that precludes the use of medical tape necessary for adherence to activity monitor measure
  10. * Inability to speak, read, or understand English
  11. * Concurrent participation in any other rehabilitation intervention research study (including cognitive and/or physical rehabilitation studies)
  12. * Investigator discretion for safety or adherence reasons

Contacts and Locations

Study Contact

Karli Jahnke, MOT, OTR/L
CONTACT
612-626-4046
dwell@umn.edu
Emily Kringle, PhD, OTR/L
CONTACT
612-626-4046
dwell@umn.edu

Principal Investigator

Emily Kringle, PhD, OTR/L
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

School of Kinesiology, University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Emily Kringle, PhD, OTR/L, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • sedentary behavior
  • physical activity
  • behavioral activation
  • activity engagement
  • occupational therapy
  • rehabilitation

Additional Relevant MeSH Terms

  • Stroke