Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial.
Yen-Nung Lin, Shih-Pin Hsu, Jiunn-Horng Kang...
https://pubmed.ncbi.nlm.nih.gov/40398954Actively Recruiting
Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID05571150
A Novel Rehabilitation Approach for Optimizing Dyadic Outcomes of Stroke Survivors and Their Caregivers: Dyadic Strategy Training
Led by Taipei Medical University · Updated on 2024-07-03
138
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new dyad-focused strategy training intervention designed to improve the participation of stroke survivors and their caregivers. Stroke often leads to social isolation and participation difficulties for both survivors and their families. This randomized controlled trial aims to compare this new intervention with a control group to understand its immediate and long-term effects on participation and self-efficacy for both members of the dyad. The study will randomly assign 138 stroke survivor-caregiver pairs to either the intervention group or a control group receiving stroke education. The intervention includes shared decision making, setting and working toward shared goals, and guided discovery strategies delivered by trained therapists either at home or in a hospital setting. Control participants will receive matched educational sessions covering stroke prevention, care, and community participation. Assessments will be conducted at baseline, post-intervention, and follow-ups at 3 and 6 months. Participants will complete standardized questionnaires and assessments measuring participation, quality of life, self-efficacy, cognitive function, and activity levels at multiple timepoints. Researchers will also conduct in-depth interviews to explore experiences and satisfaction with the intervention. The study will analyze data using statistical models to determine the effects of the intervention and gather insights to support future rehabilitation practices.
CONDITIONS
Brief Title
A Novel Rehabilitation Approach: Dyadic Strategy Training for Stroke Survivors and Their Caregivers
Who Can Participate
Age: 20Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Stroke survivors aged 20 years and older
- Diagnosed with a first-time stroke within the past two years
- Speak Mandarin
- Have an identified primary caregiver who provides care and takes responsibility
- Able to provide informed consent
- Family caregivers aged 20 years and older
- Speak Mandarin
- Recognized as the primary caregiver by the survivor
- Available to participate in intervention sessions with the survivor
- Able to provide informed consent
You will not qualify if you...
- Survivor or caregiver requires significant medical treatment that may limit participation (e.g., chemotherapy, radiation therapy, dialysis)
- Severe aphasia
- Unable to participate in a 1-hour discussion session
- Diagnosis of dementia, major depressive disorder, substance use, or other psychiatric disorders that may limit participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Up to 6 weeks
Participants receive the dyad-focused strategy training intervention or an attention-control stroke education delivered by trained therapists in-person at home or hospital settings. The intervention focuses on shared decision making and strategy development between stroke survivors and their caregivers.
1 to 2 visits per week for up to 6 weeks
Follow-up
Duration - Up to 6 months after intervention
Participants are assessed at 3-month and 6-month intervals after the intervention to evaluate the lasting effects of the training on participation, self-efficacy, and function.
2 follow-up visits (in-person or remote) at 3 and 6 months post-intervention
Trial Site Locations
Total: 1 location
1
Taipei Medical University
Taipei, Taiwan
Actively Recruiting
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Research Team
F
Feng-Hang Chang, Sc.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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