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Completed

NCT Number: NCT05964400

duoABLE for People With Stroke and Their Caregivers

The goal of this intervention study is to test whether a behavioral program that involves people with stroke and their caregivers is acceptable, safe, and can promote physically active lifestyles using enjoyable activities. Participant duos (person with stroke and their caregiver) will be asked to complete assessments at 2 timepoints, wear an activity tracker, participate in 12 sessions with an occupational therapist, and complete an interview.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Motor Activity Nervous System Diseases Stroke Hemorrhagic Stroke Ischemic Stroke Sequelae Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Kinesiology, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Stroke Participants):

  • Stroke diagnosed more than 6 months ago
  • Are 18 years of age or older
  • Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week
  • Reside in a community-based setting
  • Are mobile within their home, with or without an assistive device and without physical assistance
  • Are able to identify an eligible caregiver who will engage in assessments and intervention.

Inclusion criteria

(Caregiver Participants):

  • Are 18 years of age or older
  • Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week
  • Reside in a community-based setting
  • Are mobile within their home, with or without an assistive device and without physical assistance

Exclusion criteria

(Stroke Participants):

  • Severe aphasia
  • Are currently receiving chemotherapy or radiation treatments for cancer
  • Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
  • Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
  • Have a history of skin sensitivity related to adhesives
  • Are pregnant or expecting to become pregnant in the next 2 months
  • Reside in an institutional setting
  • Are currently incarcerated

Exclusion criteria

(Caregiver Participants):

  • Have a history of skin sensitivity related to adhesives
  • Are currently receiving chemotherapy or radiation treatments for cancer
  • Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
  • Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
  • Are pregnant or expecting to become pregnant in the next 2 months
  • Reside in an institutional setting
  • Are currently incarcerated

Treatment and study plan

duoABLE

Behavioral

Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels

Primary outcomes

  1. Participant satisfaction

    Time frame: Score at week 8

    Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)

Secondary outcomes

  1. Change in activity restrictions

    Time frame: Baseline to 8 weeks

    Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3

  2. Change in sedentary minutes per day

    Time frame: Baseline to 8 weeks

    Minutes of sedentary time per day, measured using the activPAL micro4 (mean minutes per day determined by 7-day wear protocol) at baseline and week 8.

  3. Change in daily step count

    Time frame: Baseline to 8 weeks

    Count of steps per day, measured using the activPAL micro4 (mean daily step count determined by 7-day wear protocol) at baseline and week 8.

  4. Change in Health-related quality of life

    Time frame: Baseline to 8 weeks

    Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8

  5. Adverse event count

    Time frame: Count of adverse events at week 8

    Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • American Occupational Therapy Foundation

Registry information

Official study title

duoABLE for People With Stroke and Their Caregivers (Feasibility)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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