VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers (VACARES)
2021年7月20日 更新者:VA Office of Research and Development
Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care
The purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of Veterans with dementia.
研究概览
地位
完全的
详细说明
According to VA estimates, nearly 500,000 Veterans suffer from dementia.
There is currently no cure for dementia.
Ultimately, dementia will have a large impact on quality of life in Veterans and families, lead to expensive nursing home placement, and decrease life expectancy for patients and family caregivers.
The experience of high burden in a caregiver for a Veteran with dementia increases the likelihood of permanent nursing home placement and can separate Veterans from their families.
To address the high burden of caring for a Veteran with dementia, the investigators aim to study the effect of a rehabilitative intervention for family caregivers of Veterans with dementia.
This novel approach will use video technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers.
研究类型
介入性
注册 (实际的)
32
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
-
-
California
-
Palo Alto、California、美国、94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
-
-
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
18年 及以上 (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:
Inclusion criteria -- Participants must:
- be adults (age 18)
- report distress associated with being the primary caregiver for a Veteran family member with all-cause dementia
- reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined
- provide at least one hour of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members, etc.)
- be proficient in spoken and written English
- be capable of providing informed consent
Exclusion Criteria:
Exclusion criteria -- Potential participants will be screened and excluded for:
- current or lifetime history of any psychiatric disorder with psychotic features
- prominent suicidal or homicidal ideation
- having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months
- presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation
- diagnosis of probable or possible dementia
- a Telephone Cognitive Screen score of < 20
- participation in another caregiver intervention within the past year
- lack of regular access to a telephone
- illness that would prevent 24 months of study participation
- planned transfer of care receiver to another caregiver or nursing home within 12 months
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:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition
Education and Skill-Building Rehabilitation delivered in clinic
|
ESBR intervention consists of four, 90-minute sessions over a 4-6 week period.
These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention.
Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.
其他名称:
|
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实验性的:Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition
Education and Skill-Building Rehabilitation delivered via video telehealth.
|
ESBR intervention consists of four, 90-minute sessions over a 4-6 week period.
These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention.
Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.
其他名称:
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有源比较器:Usual Care Condition
Usual Care plus supplemental paper education materials
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Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
|
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 |
|---|---|---|
|
Zarit Burden Inventory
大体时间:change from baseline at 6-months post intervention
|
The Zarit Burden Inventory is a self-report measure of caregiver burden.
Higher scores on this assessment indicate greater levels of caregiver burden.
Potential scores range from 0-88 with higher scores indicating more severe burden.
|
change from baseline at 6-months post intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Center for Epidemiological Studies-Depression
大体时间:change from baseline at 6-months
|
change in caregiver depressive symptoms as measured by the Center for Epidemiological Studies-Depression (CES-D).
Scores on the CES-D can range from 0-60 with higher scores suggesting greater depressive symptomatology.
|
change from baseline at 6-months
|
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Long-term Care Placement Status (Care Recipient)
大体时间:6-months post intervention
|
Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained
|
6-months post intervention
|
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Change in All-cause Mortality Status (Care Recipient)
大体时间:6-months post intervention
|
Based on caregiver interview, care recipient mortality status will be ascertained
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6-months post 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。
调查人员
- 首席研究员:Blake K Scanlon, PhD、VA Palo Alto Health Care System, Palo Alto, CA
- 首席研究员:Jennifer K Fairchild, PhD、VA Palo Alto Health Care System, Palo Alto, CA
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 (实际的)
2014年2月21日
初级完成 (实际的)
2019年9月30日
研究完成 (实际的)
2019年9月30日
研究注册日期
首次提交
2014年3月27日
首先提交符合 QC 标准的
2014年4月2日
首次发布 (估计)
2014年4月7日
研究记录更新
最后更新发布 (实际的)
2021年8月13日
上次提交的符合 QC 标准的更新
2021年7月20日
最后验证
2021年7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.