Comparative Effectiveness of Dementia Care Strategies in Underserved Communities
2015年5月6日 更新者：RAND
Dementia is a condition that is growing in prevalence and which harms not only the afflicted individual but also adversely affects the health of their family and other informal caregivers.
New methods for delivering comprehensive assistance to persons with dementia and their caregivers are known to be effective and can delay nursing home placement, but this study will discover 1) whether more face-to-face involvement rather than telephone delivery of this assistance will work better among poor patients in Los Angeles, and 2) if one method is better than the other, what are the differences in costs between them.
These data will enable administrators in public health care settings around the US and non-profit foundations addressing dementia patient and caregiver needs to decide what method provides the best value and the best outcome relative to its cost.
研究概览
研究类型
介入性
注册 (实际的)
144
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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Sylmar、California、美国、91342-1495
- Olive View-UCLA Medical Center
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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
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Caregivers of persons with dementia
- Caregivers must either live with the care recipient (person with dementia) or be the identified primary support
- Caregiver relationship must have been present for the prior 6 months
- Caregivers must have telephone access
- Caregivers must speak English or Spanish
- Care recipients must have a prior dementia diagnosis
- Care recipients must be living in the community other than a nursing facility
Exclusion Criteria:
- Persons with dementia, lacking an informal caregiver who can communicate in Spanish or English, or living in a long term care facility
- Caregiver lacks the capacity to consent to study participation
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：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Dementia care management in person
The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
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Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues.
Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems.
An electronic tracking tool and resource manual guide delivery of the care management protocols.
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有源比较器：Dementia care management telephone only
The dementia care management protocol will be delivered via telephonic meetings only.
Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
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Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues.
Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems.
An electronic tracking tool and resource manual guide delivery of the care management protocols.
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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 |
|---|---|---|
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Change in Caregiver Burden at 6 and 12 Months
大体时间：0, 6 and 12 months
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The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia.
Originally a 29-item instrument, the 22-item modified version is easily completed by telephone.
This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden.
Higher Zarit scores indicate greater caregiver burden.
The minimum possible score is 0, and the maximum possible score is 110.
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0, 6 and 12 months
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Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months
大体时间：0, 6 and 12 months
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The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues.
The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week.
Higher RMBPC scores mean worse memory/behavior problems.
The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24.
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0, 6 and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Caregiver Depression at 6 and 12 Months
大体时间：0, 6 and 12 months
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The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks.
The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders.
It covers each of the 9 DSM-IV depression criteria scoring them as "0" (not at all) to "3" (nearly every day).
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0, 6 and 12 months
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Change in Caregiver Quality of Life at 6 and 12 Months
大体时间：0, 6 and 12 months
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The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish.
Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.
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0, 6 and 12 months
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Change in Care Recipient Quality of Life at 6 and 12 Months
大体时间：0, 6 and 12 months
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The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population.
The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.
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0, 6 and 12 months
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Change in Process Measures of Dementia Care Quality at 6 and 12 Months
大体时间：0, 6 and 12 months
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The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes.
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0, 6 and 12 months
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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。
赞助
合作者
调查人员
- 首席研究员：Joshua Chodosh, M.D., MSHS、RAND
- 首席研究员：Barbara Vickrey, M.D., MPH、RAND
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2011年3月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2011年1月18日
首先提交符合 QC 标准的
2011年10月25日
首次发布 (估计)
2011年10月26日
研究记录更新
最后更新发布 (估计)
2015年5月22日
上次提交的符合 QC 标准的更新
2015年5月6日
最后验证
2015年5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.