A Two-Tier Care Management Program to Empower Stroke Caregivers in Hong Kong: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Family Role Performance measured by the Family Role Performance Scale (Questionnaire)
研究概览
简要总结
This study intends to develop a family-based care management intervention with primary aims to provide time-limited support for family caregivers affected by stroke and to empower caregivers through enhancing the family adaptation and functioning and increasing their capacity of stroke care. The objectives include:
- To examine the effectiveness of the proposed family-based intervention to improve family, caregiver, and service outcome.
- To examine the cost-effectiveness of the proposed family intervention.
It is hypothesized that comparing to the control group, the experimental group participants will have more and significant outcome.
详细描述
This study will recruit 300 caregivers of first stroke survivors to involve in the intervention and employ a randomized controlled trial (RCT) to assign the caregivers into the intervention group and active control group. Each group will have 150 caregivers. The intervention is individualized, tailor-made according to caregivers' needs. Care managers will conduct an initial family need assessment with caregivers to determine their care plan. The intervention will last for 2 to 3 months with 6 to 10 weekly sessions. If the caregiver participants' family member with stroke (stroke survivors) agrees to and is competent enough( see Eligibility Criteria Criteria), they will also be invited to take part in up to 4 intervention sessions.
The active control group will receive a standard, non-family-based psychoeducation intervention provided by the trained volunteers under the supervision of care managers. The active control group will not involve stroke survivors. Therefore, a maximum of 150 stroke survivors will be involved in the intervention.
Both caregivers participants (300) and their family members with stroke (300) will be asked to do questionnaires before (T1), immediately after (T2) and 2 months after (T3) the intervention. The intervention and the questionnaire interview will take place at the homes of participants.
The participation of the stroke survivors in the intervention and the questionnaire interview will not affect the involvement of their caregivers in this study. In other words, caregivers can still take part in the intervention and the questionnaire interview if their family members with stroke refuse to or are not competent ( see Eligibility Criteria Criteria) to take part in this study.
No drug usage and medical treatment will be involved in the study. Intervention and questionnaires do not impose any physical or medical risk to participants. The only possible problem may be caregivers may feel a little tired after the intervention. Participants can voluntarily drop out the study at any time, without giving any reason, without my medical care or original rights being affected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A stroke caregiver is eligible to participate in the study if:
- •He / She is a Chinese adult aged 18 or above;
- •He / She has a family member has the first stroke (ischaemic or haemorrhagic stroke) at the age of 50 or above and has been discharged from the acute hospital for no more than 6 months;
- •He / She provides care or being with the stroke survivor for no less than two hours per day after discharge from the acute hospital;
- •He / She reports significant caregiver burden as measured by the 12-item Zarit Burden Interview (a total score ≥ 12).
- •A stroke survivor is eligible to participate in the study if:
- •He / She is a Chinese adult aged 50 or above;
- •He / She has been discharged from the acute hospital for no more than 6 months;
- •His / Her family caregiver participates in this study;
- •He/ She is able to communicate with interventionists and interviewers;
- •He/ She is competent to give written informed consent.
- •Stroke survivors whose caregivers in the intervention group will receive both the intervention and the questionnaire interviews. Stroke survivors whose caregiver in the control group will only need to take part in the questionnaire interview.
排除标准
- •A stroke caregiver will be excluded from participation if:
- •His / Her family member has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke;
- •His / Her family member with stroke is residing in a residential care facility after discharge from the acute hospital;
- •He / She is diagnosed as having Alzheimer's disease or other dementias;
- •He / She is unable to understand Cantonese.
- •A stroke survivor is not eligible to participate in the study if:
- •He / She is residing in a residential care facility after discharge from the acute hospital;
- •He/ She has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke;
- •His / Her family caregiver refuses to participate in this study;
- •He/ She is not able to communicate with interventionists and interviewers;
- •He/ She is not competent to give written informed consent.
结局指标
主要结局
Family Role Performance measured by the Family Role Performance Scale (Questionnaire)
时间窗: 6 months
Family Role Performance Scale: The research team develops this scale to measure the frequency and ability of the family member to perform six major family roles, which are advisor, emotional connector, breadwinner, caretaker, decision maker and caregiver. The scale has two parts. The first part contains 6 items and asks participants how often they perform the six family roles. The second part contains 6 items and asks participants to rate their performance regarding to the family roles.
Care Management Strategies measured by the Care Management Strategies Scale (Questionnaire)
时间窗: 6 months
Care Management Strategies Scale: This is a 5-point Likert scale developed by the research team to find out the care management behaviors proposed by stroke caregivers. The scale contains 18 items.
Family Caregiver Conflict measured by Family Caregiver Conflict Scale (FCCS) (Questionnaire)
时间窗: 6 months
Family Caregiver Conflict Scale (FCCS): This is a 5-Likert-type scale with 15 items to assess family conflict due to stroke. It has four subscales: communication, problem solving, general family functioning, and perceived criticism (Clark, Shields, Aycock, \& Wolf, 2003).
Family Function measured by the Family Assessment Device-General Functioning Scale (FAD-GF) (Questionnaire)
时间窗: 6 months
Family Assessment Device-General Functioning Scale (FAD-GF): This study will use the 12-item general functioning of the McMaster Family Assessment Device (Epstein, Baldwin, \& Bishop, 1983) to measure the family functioning of caregivers. Responses are given using a 4-point Likert scale (1 = strongly agree to 4 = strongly disagree).
次要结局
- Number of hospital rehabilitation service received by stroke survivors(6 months)
- Number of day care service received by stroke survivors(6 months)
- Caregiver Burden measuewd by the Cantonese Short Version of Zarit Burden Interview (questionnaire)(6 months)
- Ambivalence between caregivers and care receivers measured by the Caregiving Ambivalence Scale (Questionnaire)(6 months)
- Health-related quality of life measured by SF-12 Health Survey (SF-12) (Questionnaire)(6 months)
- Depressive symptoms measured by the The Patient Health Questionnaire-9 (PHQ-9) (Questionnaire)(6 months)
- The mental or affective state of caregivers in relation to stressful caregiving experience measured by the Positive Aspects of Caregiving (PAC) (Questionnaire)(6 months)
- The rate of inpatient hospital admission of stroke survivors(6 months)
- Number of accident and emergency service received by stroke survivors(6 months)
- Contemporary filial piety of caregivers measured by the Contemporary Filial Piety Scale (CFPS-10) (Questionnaire)(6 months)
- Degree of disability or dependence in the daily activities of people who have suffered from a stroke measured by the Simplified Modified Rankin Scale (Questionnaire)(6 months)
- Social network of caregivers measured by the Lubben Social Network Scale (LSNS) (Questionnaire)(6 months)
- Self-rated Health measured by a question to rate their health (Questionnaire)(6 months)
- Number of specialist outpatient received by stroke survivors(6 months)
- Stroke knowledge of caregivers measured by the Stroke Knowledge Test (SKT) (Questionnaire)(6 months)
- Number of medicines received by stroke survivors(6 months)
- Number of home care service received by stroke survivors(6 months)
- Number of community rehabilitation service received by stroke survivors(6 months)
- Number of residential care service received by stroke survivors(admission after study intake)(6 months)
研究者
Dr. Vivian W.Q. Lou
Director, Sau Po Center on Ageing, Faculty of Social Science
The University of Hong Kong