duoABLE for People With Stroke and Their Caregivers

Stroke Clinical Trial

Official title:

duoABLE for People With Stroke and Their Caregivers (Feasibility)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964400
• Other study ID #: duoABLE
• Secondary ID: AOTFIRG23KRINGLE
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2023
• Source: University of Minnesota
• Contact: Karli Jahnke, MOT, OTR/L
• Phone: (612) 626-4046
• Email: dwell[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke Ischemic
• Stroke Sequelae

Intervention

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

Locations

Country	Name	City	State
United States	School of Kinesiology, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	American Occupational Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant satisfaction	Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)	Score at week 8
Secondary	Change in activity restrictions	Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3	Baseline to 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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