duoABLE for People With Stroke and Their Caregivers

NCT ID: NCT05964400

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-08-24

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.

Conditions

Stroke; Stroke Ischemic; Stroke Hemorrhagic; Stroke Sequelae

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

duoABLE

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Occupational Therapy Foundation

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily A Kringle, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

School of Kinesiology, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

AOTFIRG23KRINGLE

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

duoABLE

Identifier Type: -

Identifier Source: org_study_id