Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia (I-care)
2015年3月24日 更新者：Jeong Jee Hyang、Ewha Womans University Mokdong Hospital
A Multicenter, Randomized Trial to Assess Efficacy of Therapeutic Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
80
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- illiterate
- severe hearing/visual acuity difficulty
- cognitive impairment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control
Basic information about dementia
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有源比较器：Behavioral intervention
Individual, 90 min a day, with an interval of 2 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
大体时间：baseline/10-12 week (after intervention)
|
Zaret's Burden Inventory (ZBI)
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baseline/10-12 week (after intervention)
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Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
大体时间：baseline/10-12 week (after intervention)
|
Philadelphia Geriatric Center for Moral Scale (PGCMS)
|
baseline/10-12 week (after intervention)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory
大体时间：baseline/10-12 week (after intervention)
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Neuropsychiatry inventory
|
baseline/10-12 week (after intervention)
|
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Changes in Depression of caregivers as assessed by the geriatric depression scale
大体时间：baseline/10-12 week (after intervention)
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Geriatric depression scale
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baseline/10-12 week (after intervention)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年3月1日
初级完成 (预期的)
2015年12月1日
研究完成 (预期的)
2016年12月1日
研究注册日期
首次提交
2015年3月13日
首先提交符合 QC 标准的
2015年3月24日
首次发布 (估计)
2015年3月25日
研究记录更新
最后更新发布 (估计)
2015年3月25日
上次提交的符合 QC 标准的更新
2015年3月24日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Behavioral intervention的临床试验
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of North Carolina, Chapel HillWuhan Center for Disease Control and Prevention完全的