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duoABLE for People With Stroke and Their Caregivers

Primary Purpose

Stroke, Stroke Ischemic, Stroke Hemorrhagic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
duoABLE
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring lifestyle, physical activity, duoABLE, ABLE, rehabilitation, rehab, occupational therapy, physical therapy, stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Kinesiology, University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

duoABLE

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in activity restrictions
Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3
Change in sedentary minutes per day
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.
Change in daily step count
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.
Change in Health-related quality of life
Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8
Adverse event count
Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks

Full Information

First Posted
July 18, 2023
Last Updated
October 6, 2023
Sponsor
University of Minnesota
Collaborators
American Occupational Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05964400
Brief Title
duoABLE for People With Stroke and Their Caregivers
Official Title
duoABLE for People With Stroke and Their Caregivers (Feasibility)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
American Occupational Therapy Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Ischemic, Stroke Hemorrhagic, Stroke Sequelae
Keywords
lifestyle, physical activity, duoABLE, ABLE, rehabilitation, rehab, occupational therapy, physical therapy, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
duoABLE
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
duoABLE
Intervention Description
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 Outcome Measure Information:
Title
Participant satisfaction
Description
Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame
Score at week 8
Secondary Outcome Measure Information:
Title
Change in activity restrictions
Description
Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3
Time Frame
Baseline to 8 weeks
Title
Change in sedentary minutes per day
Description
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.
Time Frame
Baseline to 8 weeks
Title
Change in daily step count
Description
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.
Time Frame
Baseline to 8 weeks
Title
Change in Health-related quality of life
Description
Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8
Time Frame
Baseline to 8 weeks
Title
Adverse event count
Description
Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks
Time Frame
Count of adverse events at week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karli Jahnke, MOT, OTR/L
Phone
(612) 626-4046
Email
dwell@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily A Kringle, PhD, OTR/L
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Kinesiology, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karli Jahnke, MOT, OTR/L
Phone
612-626-4046
Email
dwell@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

duoABLE for People With Stroke and Their Caregivers

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