A Novel Rehabilitation Approach for Optimizing Dyadic Outcomes of Stroke Survivors and Their Caregivers: Dyadic Strategy Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
时间窗: From baseline to up to 6 weeks
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
次要结局
- 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 30 weeks)
- Stroop Test(From baseline to up to 30 weeks)
- Montreal Cognitive Assessment (MoCA)(From baseline to up to 30 weeks)
- TMT Test(From baseline to up to 30 weeks)
- Activity Measure for Post-Acute Care (AM-PAC) Short Forms(From baseline to up to 30 weeks)
- Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)(From baseline to up to 30 weeks)
研究者
Feng-Hang Chang
Professor
Taipei Medical University