duoABLE for People With Stroke and Their Caregivers

duoABLE for People With Stroke and Their Caregivers (Feasibility)

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Stroke Sequelae; Stroke Hemorrhagic; Stroke Ischemic
• Intervention / Treatment: Behavioral: duoABLE

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • School of Kinesiology, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)	Score at week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in activity restrictions	Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3	Baseline to 8 weeks
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.	Baseline to 8 weeks
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.	Baseline to 8 weeks
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	Baseline to 8 weeks
Adverse event count	Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks	Count of adverse events at week 8

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: American Occupational Therapy Foundation
• Investigators: Principal Investigator: Emily A Kringle, PhD, OTR/L, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): August 24, 2024
• Study Completion (Actual): August 24, 2024

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; stroke; rehabilitation; physical therapy; occupational therapy; lifestyle; rehab; duoABLE; ABLE
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: duoABLE; AOTFIRG23KRINGLE (Other Grant/Funding Number: American Occupational Therapy Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No