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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dyad-focused strategy training intervention
Attention-control intervention
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Taipei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental intervention group

Control intervention group

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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".
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".
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."
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."
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."
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.
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.
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.
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.
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.
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.
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.
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.
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.
TMT Test
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
TMT Test
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
TMT Test
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
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.
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.

Full Information

First Posted
October 5, 2022
Last Updated
March 31, 2023
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05571150
Brief Title
A Novel Rehabilitation Approach: Dyadic Strategy Training for Stroke Survivors and Their Caregivers
Official Title
A Novel Rehabilitation Approach for Optimizing Dyadic Outcomes of Stroke Survivors and Their Caregivers: Dyadic Strategy Training
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control intervention group
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Behavioral
Intervention Name(s)
Dyad-focused strategy training intervention
Intervention Description
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
Intervention Name(s)
Attention-control intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Description
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time Frame
From baseline to up to 6 weeks
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life (WHOQOL-Brief)
Description
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".
Time Frame
From baseline to up to 6 weeks
Title
World Health Organization Quality of Life (WHOQOL-Brief)
Description
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".
Time Frame
From baseline to up to 18 weeks
Title
World Health Organization Quality of Life (WHOQOL-Brief)
Description
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".
Time Frame
From baseline to up to 30 weeks
Title
General Self-Efficacy Scale (GSES)
Description
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."
Time Frame
From baseline to up to 6 weeks
Title
General Self-Efficacy Scale (GSES)
Description
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."
Time Frame
From baseline to up to 18 weeks
Title
General Self-Efficacy Scale (GSES)
Description
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."
Time Frame
From baseline to up to 30 weeks
Title
Activity Measure for Post-Acute Care (AM-PAC) Short Forms
Description
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.
Time Frame
From baseline to up to 6 weeks
Title
Activity Measure for Post-Acute Care (AM-PAC) Short Forms
Description
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.
Time Frame
From baseline to up to 18 weeks
Title
Activity Measure for Post-Acute Care (AM-PAC) Short Forms
Description
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.
Time Frame
From baseline to up to 30 weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
From baseline to up to 6 weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
From baseline to up to 18 weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
From baseline to up to 30 weeks
Title
Stroop Test
Description
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.
Time Frame
From baseline to up to 6 weeks
Title
Stroop Test
Description
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.
Time Frame
From baseline to up to 18 weeks
Title
Stroop Test
Description
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.
Time Frame
From baseline to up to 30 weeks
Title
TMT Test
Description
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
Time Frame
From baseline to up to 6 weeks
Title
TMT Test
Description
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
Time Frame
From baseline to up to 18 weeks
Title
TMT Test
Description
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
Time Frame
From baseline to up to 30 weeks
Title
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Description
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time Frame
From baseline to up to 18 weeks
Title
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
Description
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time Frame
From baseline to up to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; has reported desire to change in any participation domain (screened by the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D); 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; 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng-Hang Chang, Sc.D.
Phone
886-2-2736-1661
Ext
6573
Email
fhchang@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng-Hang Chang
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng-Hang Chang
Phone
886-2-2736-1661
Ext
6573
Email
fhchang@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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