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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571150
• Other study ID #: N202203083
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Taipei Medical University
• Contact: Feng-Hang Chang, Sc.D.
• Phone: 886-2-2736-1661
• Email: fhchang[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 110 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.

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 110 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), 6-month (T4), and 12-month (T5) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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. has reported desire to change in any participation domain (screened by the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D);

6. 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. has reported desire to change in any participation domain (screened by the PM-3D4D; (6) 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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	World Health Organization Quality of Life (WHOQOL-Brief)	The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".	From baseline to up to 6 weeks
Secondary	World Health Organization Quality of Life (WHOQOL-Brief)	The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".	From baseline to up to 18 weeks
Secondary	World Health Organization Quality of Life (WHOQOL-Brief)	The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".	From baseline to up to 30 weeks
Secondary	General Self-Efficacy Scale (GSES)	The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."	From baseline to up to 6 weeks
Secondary	General Self-Efficacy Scale (GSES)	The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."	From baseline to up to 18 weeks
Secondary	General Self-Efficacy Scale (GSES)	The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."	From baseline to up to 30 weeks
Secondary	Activity Measure for Post-Acute Care (AM-PAC) Short Forms	The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.	From baseline to up to 6 weeks
Secondary	Activity Measure for Post-Acute Care (AM-PAC) Short Forms	The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.	From baseline to up to 18 weeks
Secondary	Activity Measure for Post-Acute Care (AM-PAC) Short Forms	The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.	From baseline to up to 30 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health.; The score ranges from 0 to 30. A score of 26 and higher is considered normal.	From baseline to up to 6 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health.; The score ranges from 0 to 30. A score of 26 and higher is considered normal.	From baseline to up to 18 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health.; The score ranges from 0 to 30. A score of 26 and higher is considered normal.	From baseline to up to 30 weeks
Secondary	Stroop Test	The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.	From baseline to up to 6 weeks
Secondary	Stroop Test	The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.	From baseline to up to 18 weeks
Secondary	Stroop Test	The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.	From baseline to up to 30 weeks
Secondary	TMT Test	The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.	From baseline to up to 6 weeks
Secondary	TMT Test	The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.	From baseline to up to 18 weeks
Secondary	TMT Test	The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.	From baseline to up to 30 weeks
Secondary	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 18 weeks
Secondary	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 30 weeks