duoABLE for People With Stroke and Their Caregivers

University of Minnesota16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Stroke Ischemic Stroke Hemorrhagic Stroke Sequelae

Interventions

duoABLEBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

School of Kinesiology, University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Participant satisfaction

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

Time frame: Score at week 8

Secondary Outcomes

Change in activity restrictions

Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Count of adverse events at week 8

Data from ClinicalTrials.gov

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