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

NCT ID: NCT05571150

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2026-07-31

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.

Detailed Description

Stroke is the leading cause of death and adult disability. Stroke survivors and their caregivers often experience an overwhelming sense of social isolation and experience a wide range of participation restrictions after stroke, leading to frustration and adverse health outcomes. To address both the survivor and caregiver needs, dyad-focused interventions are necessary to be implemented in the transitioning process. However, very few interventions were designed to address the needs of the dyad and place an equal emphasis on both survivors' and caregivers' outcomes. 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. These participants will be randomly assigned to the intervention group and the control group at a 1:1 ratio. Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), General Self-Efficacy Scale (GSES), Activity Measure for Post-Acute Care (AM-PAC), and other standardized assessment tools and questionnaires will be administered to the participants at baseline (T1), post-intervention (T2), and 3-month (T3), and 6-month (T4) follow-ups. 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. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected. Transcribed data will be coded by two independent coders and analyzed with thematic analysis method.

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. The mechanism of whether and how this intervention program impacts the dyad's self-efficacy and the functions of stroke survivors in addition to participation will also be identified. These findings will together support the application of the dyad-focused strategy training intervention in rehabilitation practice and inform future study development.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental intervention group

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.

Group Type: EXPERIMENTAL

Dyad-focused strategy training intervention

Intervention Type: 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.

Control intervention group

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 .

Group Type: ACTIVE_COMPARATOR

Attention-control intervention

Intervention Type: 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.

Interventions

Dyad-focused strategy training intervention

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.

Intervention Type: BEHAVIORAL

Attention-control intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Stroke survivors

1. ages 20 years and older;

2. has been diagnosed with a first-time stroke within the past two year;

3. speaks Mandarin;

4. has an identified primary caregiver who provides care or assistance of any kind and taking responsibility for the survivor;

5. is able to provide informed consent.

• Family caregivers include that the caregiver

1. ages 20 years and older;

2. speaks Mandarin;

3. is the primary caregiver recognized by the survivor;

4. is available to participate in the intervention sessions with the survivor;

5. is able to provide informed consent.

Exclusion Criteria

• The survivor-caregiver dyad will be excluded if any of them:

1. requires significant medical treatment (e.g., chemotherapy, radiation therapy, or hemo/peritoneal dialysis) that may impede them from participating in the study;

2. has severe aphasia;

3. is unable to participate in a 1-hour discussion session;

4. has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede them from participating in the study.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng-Hang Chang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng-Hang Chang

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Feng-Hang Chang, Sc.D.

Role: CONTACT

fhchang@tmu.edu.tw

886-2-2736-1661 ext. 6573

Facility Contacts

Feng-Hang Chang

Role: primary

fhchang@tmu.edu.tw

886-2-2736-1661 ext. 6573

References

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.

Reference Type: DERIVED

PMID: 40398954 (View on PubMed)

Other Identifiers

N202203083

Identifier Type: -

Identifier Source: org_study_id