A Novel Rehabilitation Approach: Dyadic Strategy Training for Stroke Survivors and Their Caregivers

NCT05571150 | Recruiting

• 1 other identifier: N202203083
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the efficacy of a newly developed dyad-focused strategy training intervention on enhancing participation of stroke survivors and their caregivers. To address this purpose, a single-blinded, parallel-group randomized controlled trial will be implemented to assess the efficacy of the dyad-focused strategy training intervention in comparison to the control group. An expected sample of 138 stroke survivor-caregiver dyads will be recruited from our collaborative hospitals in Northern Taiwan. Data will be analyzed using multiple linear regression models and mixed-effects regression models. Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Findings of this study will provide important evidence on whether this newly-developed program has immediate and long-term effect on improving and maintaining participation for both stroke survivors and their caregivers. These findings will together support the application of the dyad-focused strategy training intervention in rehabilitation practice and inform future study development.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)

  The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.

  From baseline to up to 6 weeks

Secondary Outcomes (20)

• World Health Organization Quality of Life (WHOQOL-Brief)

  From baseline to up to 6 weeks

• World Health Organization Quality of Life (WHOQOL-Brief)

  From baseline to up to 18 weeks

• World Health Organization Quality of Life (WHOQOL-Brief)

  From baseline to up to 30 weeks

• General Self-Efficacy Scale (GSES)

  From baseline to up to 6 weeks

• General Self-Efficacy Scale (GSES)

  From baseline to up to 18 weeks

Study Arms (2)

Experimental intervention group

EXPERIMENTAL

The dyad-focused strategy training intervention will be delivered to the treatment group. The intervention protocols of the dyad-focused strategy training were developed based on the strategy training guideline outlined by Skidmore et al, Bodenmann's framework of dyadic coping, and the self-efficacy theory.

Behavioral: Dyad-focused strategy training intervention

Control intervention group

ACTIVE COMPARATOR

Participants in the control group will receive a dose-matched stroke education provided by a trained research therapist as an attention-control intervention. The therapist will provide in-person education to the dyad using an illustrated manual developed based on the stroke rehabilitation guidelines suggested by the American Heart Association/American Stroke Association .

Behavioral: Attention-control intervention

Interventions

Dyad-focused strategy training intervention BEHAVIORAL

The program consists of five critical ingredients: shared decision making, self-selected goals, self-evaluation of performance, strategy development and implementation, and therapeutic guided discovery. Trained research therapists will deliver the intervention to the survivor-caregiver dyads on a one-to-two base at the participants' home or in a quiet room at our collaborative hospitals. The therapist will ask the dyad to identify 3 to 5 shared participation goals and provide them the global strategy (also called guided discovery strategy), which involves (1) setting a goal to address the barriers, (2) developing a plan to address the goal, (3) doing the plan, and (4) checking if the plan worked or required revising. This procedure will be repeated iteratively until the dyad's goal is met, and the next goal can be moved on to.

Experimental intervention group

Attention-control intervention BEHAVIORAL

The topics of the education will cover: (1) secondary stroke prevention; (2) prevention and management of comorbidities; (3) managing emotions and behaviors; (3) medications and personal care; (4) finances and transportation; and (5) home and community-based participation.

Control intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors
• ages 20 years and older;
• has been diagnosed with a first-time stroke within the past two year;
• speaks Mandarin;
• has an identified primary caregiver who provides care or assistance of any kind and taking responsibility for the survivor;
• is able to provide informed consent.
• Family caregivers include that the caregiver
• ages 20 years and older;
• speaks Mandarin;
• is the primary caregiver recognized by the survivor;
• is available to participate in the intervention sessions with the survivor;
• is able to provide informed consent.

You may not qualify if:

• The survivor-caregiver dyad will be excluded if any of them:
• requires significant medical treatment (e.g., chemotherapy, radiation therapy, or hemo/peritoneal dialysis) that may impede them from participating in the study;
• has severe aphasia;
• is unable to participate in a 1-hour discussion session;
• has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede them from participating in the study.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

RECRUITING

Related Publications (1)

• Lin YN, Hsu SP, Kang JH, Liou TH, Han DS, Ni P, Chiu V, Rodakowski J, Chang FH. Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial. BMJ Open. 2025 May 21;15(5):e090751. doi: 10.1136/bmjopen-2024-090751.

  PMID: 40398954 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Feng-Hang Chang

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Hang Chang, Sc.D.

CONTACT

886-2-2736-1661; fhchang@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: October 5, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)