Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Zarit Burden Interview-12 (ZBI-12)
研究概览
简要总结
This is a cluster randomized controlled trial to test the efficacy of a psychosocial intervention to support family caregivers of persons living with dementia in Vietnam.
详细描述
The objective of this study is to conduct a cluster randomized controlled trial (RCT) to test the efficacy of a psychosocial intervention to support Alzheimer's family caregivers in Vietnam. The cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower psychological distress and lower caregiver burden compared with those in the control group (primary outcomes). In addition, we will conduct secondary analyses to examine whether the intervention group has lower perceived stress and somatic symptoms. Exploratory analyses will be conducted to determine if intervention effects are mediated by caregiver self-efficacy or knowledge gain.
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
- Single (Outcomes Assessor)
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
- •To be eligible for the cluster RCT, the family member will need to be the identified adult (age 18 and above) primary caregiver (i.e. the person spending who provides the most time day-to-day providing care) to an older adult with dementia who is living in the community. In the event that the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) to the older adult with dementia will be eligible.
- •Caregivers will need to score ≥ 6 on the Zarit Burden Inventory 4-item version.
- •All participants will be living in designated clusters in Hai Duong, Vietnam.
- •To be eligible, clusters will have a minimum of 5 participants and a maximum of 15 participants. Clusters will be defined as geographic areas serving local health stations.
排除标准
- •Significant cognitive impairment or sensory deficit.
研究组 & 干预措施
Enhanced control
A single session focused on education about the nature of dementia.
干预措施: Enhanced control (Behavioral)
REACH VN
A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months.
干预措施: REACH VN (Behavioral)
结局指标
主要结局
Zarit Burden Interview-12 (ZBI-12)
时间窗: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
The Zarit Burden Interview-12 (ZBI-12) asked caregivers to rate on a scale of 0 (never) to 4 (nearly always) how often they have experienced feelings of burden or stress related to caregiving (total score range: 0-48). A higher score indicates a higher feel of burden.
Patient Health Questionnaire-4 (PHQ-4)
时间窗: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Patient Health Questionnaire-4 (PHQ-4) asked caregivers to rate on a scale of 0 (not at all) to 3 (nearly every day) how often they have been bothered by symptoms (e.g., feeling nervous, anxious, or on edge) over the past two weeks (total score range: 0-12). A higher score indicates a higher severity.
次要结局
- Perceived Stress Scale (PSS-10)(Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months)
- Patient Health Questionnaire-15 (PHQ-15)(Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months)