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teleABLE to Reduce Post-Stroke Sedentary Behavior

teleABLE to Reduce Post-Stroke Sedentary Behavior

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 details
    Stroke

NCT06312709

University of Minnesota

14 April 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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