A Multicenter, Randomized Trial to Assess Efficacy of Therapeutic Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
研究概览
简要总结
The purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).
详细描述
This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The intervention program includes not only the knowledge of dementia and how to manage behavioral problems of patients with dementia but also individual psychological counselling about caregiver's distress. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS). Secondary outcomes are changes in scores of neuropsychiatric inventory and Korean -instrumental Activities of Daily Living of patients as well as depression scores of caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30-80years old
- •Caregivers who spend their own time with dementia patients over 4 hours a day
- •caregiver distress scores >= 2
- •caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10~26)
排除标准
- •illiterate
- •severe hearing/visual acuity difficulty
- •cognitive impairment
结局指标
主要结局
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
时间窗: baseline/10-12 week (after intervention)
Zaret's Burden Inventory (ZBI)
Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
时间窗: baseline/10-12 week (after intervention)
Philadelphia Geriatric Center for Moral Scale (PGCMS)
次要结局
- Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory(baseline/10-12 week (after intervention))
- Changes in Depression of caregivers as assessed by the geriatric depression scale(baseline/10-12 week (after intervention))
研究者
Jeong Jee Hyang
Professor
Ewha Womans University Mokdong Hospital