duoABLE for People With Stroke and Their Caregivers

University of Minnesota (UMN)

Status: Completed

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

Treatments: Behavioral: duoABLE

Study type: Interventional

Funder types: Other

Identifiers

NCT05964400

duoABLE

AOTFIRG23KRINGLE (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

duoABLE

Experimental group

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

Treatment:

Behavioral: duoABLE