duoABLE for People With Stroke and Their Caregivers

Not Applicable

Completed

• Conditions: Stroke; Stroke Ischemic; Stroke Hemorrhagic; Stroke Sequelae

• Registration Number: NCT05964400
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Study Start: 2023-09-01
• Primary Completion: 2024-08-24
• Study Completion: 2024-08-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Participant satisfaction	Score at week 8	Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)

Secondary Outcome Measures

Name	Time	Method
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.
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
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 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

Trial Locations

Locations (1)

School of Kinesiology, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States