Family-centered Support Program for Caregivers of Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Change from baseline depressive symptoms at first month
研究概览
简要总结
The goal of this study is to evaluate the effect of a family-centered support program on the care burden, depressive symptoms, perceived social support, and quality of life of stroke survivor' caregivers and on care recipients' rehabilitation adherence and depressive symptoms.
详细描述
The family-centered support program included stroke and rehabilitation education, problem-solving skills training, long-term care information support, and instant messaging applications-based 24-h peers-support group for caregivers.
Investigators hypothesized that (1) Compared with those in the control group, caregivers who undergo a family-centered support program have lower care burdens, do not have a high risk of depression, and perceive better social support and quality of life; (2) Compared with those in the control group, care recipients in the family-centered support group have ideal rehabilitation adherence and are not at a high risk of depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
To prevent contact between participants in the intervention and control groups, we allocated participants from the G ward to the intervention group and those from the H ward to the control group. Participants were not given information about the group allocations.
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
- •Caregivers:
- •Aged 20 years or older
- •Primarily responsible for caring for the stroke survivor in the hospital and after discharge.
- •Stroke survivors:
- •Diagnosed with moderate stroke (National Institute of Health Stroke Scale ≥5 or Modified Rank in Scale ≥3), including ischemic and hemorrhagic stroke, via computed tomography or magnetic resonance imaging within one month. admitted to the stroke unit at a medical center
- •Had a primary family caregiver.
排除标准
- •Caregivers:
- •Refusal to participate in the study
- •Unable to communicate, for example, non-Chinese speakers
- •Reported having been diagnosed with psychiatric illness (such as major depression) and undergoing treatment.
- •Stroke survivors:
- •Unstable vital signs
- •Terminal illness
- •Transfer to long-term care facilities after hospital discharge
- •Self-reported having been diagnosed with psychiatric illness (such as major depression) and undergoing treatment.
结局指标
主要结局
Change from baseline depressive symptoms at first month
时间窗: The outcome was assessed at first month after inclusion.
Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
Change from baseline caregivers' quality of life at first month
时间窗: The outcome was assessed at first month after inclusion.
Taiwanese version of the World Health Organization Quality of Life BREF(WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life.WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
Depressive symptoms
时间窗: The outcome was assessed at baseline.
Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
Caregiver care burden
时间窗: The outcome was assessed at baseline.
The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
Perceived social support
时间窗: The outcome was assessed at baseline.
Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
Rehabilitation adherence
时间窗: The outcome was assessed at baseline.
A single item of rehabilitation adherence measurement was used to measure stroke Patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.
Change from baseline perceived social support at first month
时间窗: The outcome was assessed at first month after inclusion.
Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
Change from baseline depressive symptoms at third month
时间窗: The outcome was assessed at third after inclusion.
Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
Change from baseline perceived social support at third month
时间窗: The outcome was assessed at third after inclusion.
Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
Caregivers' quality of life
时间窗: The outcome was assessed at baseline.
Taiwanese version of the World Health Organization Quality of Life BREF(WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life. WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
Change from baseline caregiver care burden at first month
时间窗: The outcome was assessed at first month after inclusion.
The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
Change from baseline caregiver care burden at third month
时间窗: The outcome was assessed at third after inclusion.
The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
Change from baseline caregivers' quality of life at third month
时间窗: The outcome was assessed at third after inclusion.
Taiwanese version of the World Health Organization Quality of Life BREF (WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life. WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
Change from baseline rehabilitation adherence at first month
时间窗: The outcome was assessed at first month after inclusion.
A single item of rehabilitation adherence measurement was used to measure stroke patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.
Change from baseline rehabilitation adherence at third month
时间窗: The outcome was assessed at third after inclusion.
A single item of rehabilitation adherence measurement was used to measure stroke patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.
次要结局
未报告次要终点
研究者
wen yu Kuo, assistant professor
assistant professor
Chang Gung Memorial Hospital