duoABLE for People With Stroke and Their Caregivers

NCT05964400 | Completed

• 2 other identifiers: duoABLEAOTFIRG23KRINGLE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

lifestyle; physical activity; duoABLE; ABLE; rehabilitation; rehab; occupational therapy; physical therapy; stroke

Outcome Measures

Primary Outcomes (1)

• Participant satisfaction

  Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)

  Score at week 8

Secondary Outcomes (5)

• Change in activity restrictions

  Baseline to 8 weeks

• Change in sedentary minutes per day

  Baseline to 8 weeks

• Change in daily step count

  Baseline to 8 weeks

• Change in Health-related quality of life

  Baseline to 8 weeks

• Adverse event count

  Count of adverse events at week 8

Study Arms (1)

duoABLE

EXPERIMENTAL

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

Interventions

duoABLE 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

duoABLE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• American Occupational Therapy Foundation: collaborator

Study Sites (1)

School of Kinesiology, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Emily A Kringle, PhD, OTR/L

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion: August 24, 2024
• Study Completion: August 24, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)