Adopting Dyad-focused Strategy Training to Stroke Survivors and Their Caregivers
NCT ID: NCT05185271
Last Updated: 2024-04-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
16 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-16
Study Completion Date
2023-06-30
Brief Summary
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The purpose of this study is to develop a dyad-focused intervention built upon the theoretical tenets of strategy training to help prepare stroke survivors and their caregivers to transit to community living. The study will involve two phases.
In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads.
A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited.
The participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes at baseline, post-intervention, and 3-month and 6-month follow-ups. Quantitative data will be analyzed descriptively.
In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads.
A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited.
The participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes at baseline, post-intervention, and 3-month and 6-month follow-ups. Quantitative data will be analyzed descriptively.
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Detailed Description
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Stroke is the leading cause of death and adult disability. Transitioning from hospital to home is a challenging process for stroke survivors and their families, leading to frustration and adverse health outcomes for survivors and caregivers. 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 develop a dyad-focused intervention built upon the theoretical tenets of strategy training to help prepare stroke survivors and their caregivers to transit to community living. The study will involve two phases. In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads.
A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited. Adult stroke survivors who have been diagnosed with stroke, are about to be discharged from inpatient wards to home or has been discharged home within the past 3 months, have an identified adult caregiver who provides care or assistance of any kind and taking responsibility for the survivor and is available to participate in the intervention sessions with the survivor will be eligible to participate in the study. These participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes such as goal attainment, quality of life, self-efficacy, participation, depressive symptoms, and survivor-caregiver relationship at baseline, post-intervention, and 3-month and 6-month follow-ups. The feasibility indicators, such as recruitment rates and intervention attendance and adherence, will be evaluated by questionnaires, field notes, and qualitative interviews after the interventions are completed.
Quantitative data will be analyzed descriptively; while data obtained from the outcome measures will be examined using Wilcoxon signed rank test and effect size (r) to compare the differences between the pre- and post-intervention scores. Qualitative data will be analyzed using thematic analysis method.
The purpose of this study is to develop a dyad-focused intervention built upon the theoretical tenets of strategy training to help prepare stroke survivors and their caregivers to transit to community living. The study will involve two phases. In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads.
A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited. Adult stroke survivors who have been diagnosed with stroke, are about to be discharged from inpatient wards to home or has been discharged home within the past 3 months, have an identified adult caregiver who provides care or assistance of any kind and taking responsibility for the survivor and is available to participate in the intervention sessions with the survivor will be eligible to participate in the study. These participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes such as goal attainment, quality of life, self-efficacy, participation, depressive symptoms, and survivor-caregiver relationship at baseline, post-intervention, and 3-month and 6-month follow-ups. The feasibility indicators, such as recruitment rates and intervention attendance and adherence, will be evaluated by questionnaires, field notes, and qualitative interviews after the interventions are completed.
Quantitative data will be analyzed descriptively; while data obtained from the outcome measures will be examined using Wilcoxon signed rank test and effect size (r) to compare the differences between the pre- and post-intervention scores. Qualitative data will be analyzed using thematic analysis method.
Conditions
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Stroke
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Dyad- focused strategy training intervention
The dyad-focused strategy training intervention protocol will be developed to help dyads manage the needs that they have as transitioning to the community.
The following theoretical frameworks and guidelines will be used to guide the development of the intervention: (1) the strategy training guideline outlined by Skidmore et al; (2) Bodenmann's framework of dyadic coping; and (3) Self-efficacy theory.
Group Type
EXPERIMENTAL
Dyad-focused strategy training
Intervention Type
BEHAVIORAL
Rehabilitation therapists will be hired to deliver the intervention to the stroke survivors-caregiver dyads on a one-to-two base. The therapist will ask the dyad to identify their shared goals and provide them the global strategy "Goal-Plan-Do-Check" (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.
Interventions
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Dyad-focused strategy training
Rehabilitation therapists will be hired to deliver the intervention to the stroke survivors-caregiver dyads on a one-to-two base. The therapist will ask the dyad to identify their shared goals and provide them the global strategy "Goal-Plan-Do-Check" (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
Eligibility Criteria
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Inclusion Criteria
Stroke survivors include that the survivor:
1. ages 20 years and older;
2. has been diagnosed with stroke;
3. speaks Mandarin;
4. is about to be discharged from inpatient wards to home or has been discharged home within the past 3 months;
5. has an identified primary caregiver;
6. is able to provide informed consent.
Caregivers include that the caregiver:
1. ages 20 years and older;
2. speaks Mandarin;
3. is the primary caregiver recognized by the survivor (living with the survivor or providing daily care to the survivor for at least 10 hours per week);
4. is available to participate in the intervention sessions with the survivor;
5. is able to provide informed consent.
1. ages 20 years and older;
2. has been diagnosed with stroke;
3. speaks Mandarin;
4. is about to be discharged from inpatient wards to home or has been discharged home within the past 3 months;
5. has an identified primary caregiver;
6. is able to provide informed consent.
Caregivers include that the caregiver:
1. ages 20 years and older;
2. speaks Mandarin;
3. is the primary caregiver recognized by the survivor (living with the survivor or providing daily care to the survivor for at least 10 hours per week);
4. is available to participate in the intervention sessions with the survivor;
5. is able to provide informed consent.
Exclusion Criteria
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 continually 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 continually participating in the study.
Minimum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Taipei Medical University
OTHER
Sponsor Role
lead
Responsible Party
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Feng-Hang Chang
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Feng-Hang Chang
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University
Locations
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Taipei Medical University
Taipei, , Taiwan
Site Status
Countries
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Taiwan
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N202106087
Identifier Type: -
Identifier Source: org_study_id
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