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duoABLE for People With Stroke and Their Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05964400
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : October 10, 2023
Sponsor:
Collaborator:
American Occupational Therapy Foundation
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Stroke Ischemic Stroke Hemorrhagic Stroke Sequelae Behavioral: duoABLE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: duoABLE for People With Stroke and Their Caregivers (Feasibility)
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arms and Interventions
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Arm Intervention/treatment
Experimental: duoABLE
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
 Behavioral: duoABLE
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


Outcome Measures
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Primary Outcome Measures :
  1. Participant satisfaction [ Time Frame: Score at week 8 ]
    Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05964400


Contacts
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Contact: Karli Jahnke, MOT, OTR/L (612) 626-4046 dwell@umn.edu

Locations
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United States, Minnesota
School of Kinesiology, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Karli Jahnke, MOT, OTR/L    612-626-4046    dwell@umn.edu   
Sponsors and Collaborators
University of Minnesota
American Occupational Therapy Foundation
Investigators
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Principal Investigator: Emily A Kringle, PhD, OTR/L University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05964400    
Other Study ID Numbers: duoABLE
AOTFIRG23KRINGLE ( Other Grant/Funding Number: American Occupational Therapy Foundation )
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There are no current plans to share data with other investigators. Upon the completion of the study, a de-identified dataset that includes questionnaire data, raw and processed activPAL data, and transcribed interview data will be created and stored in the DWELL Laboratory at the University of Minnesota. The PI will consider individual requests for data sharing and provide only the necessary de-identified data upon reasonable request, under a University of Minnesota data use agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
lifestyle
physical activity
duoABLE
ABLE
rehabilitation
 rehab
occupational therapy
physical therapy
stroke
Additional relevant MeSH terms:
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Stroke
Hemorrhagic Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases