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Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth (teleABLE)

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Stroke
Stroke Hemorrhagic
Stroke, Ischemic

Treatments

Behavioral: teleABLE

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05029284
2021-0059
K23HL159240 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time.

The purpose of this research is to test whether the teleABLE (Activating Behavior for Lasting Engagement) Intervention is feasible and acceptable to adults within the first 12 months post-stroke. The hypothesis is that teleABLE can be feasibly delivered using videoconferencing within the first 12 months post-stroke. 10 participants will complete assessments and activity monitoring (activPAL micro3) at 0 (baseline) and 8 (post-intervention)-weeks. Participants will complete 12 sessions of the teleABLE intervention.

Findings from this study will be used to guide the intervention protocol in the planned next phase of this research.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Stroke diagnosis ≤12 months prior to study enrollment
  • ≥6 hours of sedentary behavior on a typical weekday (assessed by Sedentary Behavior Questionnaire)
  • Ambulatory 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 the participant has 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 (assessed by 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 in hospice care
  • 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 another rehabilitation intervention research study
  • Investigator discretion for safety or adherence reasons

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

teleABLE
Experimental group
Description:
Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook.
Treatment:
Behavioral: teleABLE

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Emily Kringle, PhD, OTR/L; Karli Jahnke, MOT, OTR/L

Data sourced from clinicaltrials.gov

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