duoABLE for People With Stroke and Their Caregivers

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05964400

Collaborator

American Occupational Therapy Foundation (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke Ischemic Stroke Hemorrhagic Stroke Sequelae	Behavioral: duoABLE	N/A

Study Design

Study Type:

Interventional

Anticipated 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)

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Participant satisfaction [Score at week 8]
Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)

Secondary Outcome Measures

Change in activity restrictions [Baseline to 8 weeks]
Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3
Change in sedentary minutes per day [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.
Change in daily step count [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.
Change in Health-related quality of life [Baseline to 8 weeks]
Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8
Adverse event count [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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