An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
2016年12月15日 更新者:Helen Kales、University of Michigan
Behavioral symptoms that commonly occur with dementia are associated with increased health care utilization and can lead to challenges for the person living with dementia and their caregivers.
Caregivers need knowledge and skills to monitor these behaviors, to identify what triggers them, and to learn how to use proven, practical medication-free strategies to prevent and manage the behaviors.
The purpose of this study is to develop and test the WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps them to assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management.
This study is a collaboration between researchers at the University of Michigan and Johns Hopkins University.
研究概览
研究类型
介入性
注册 (实际的)
114
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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Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins School of Nursing
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Department of Psychiatry
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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:
General
- Age 21 years or older
- Ability to read, speak and understand English
- Home location within 50 miles of the study site Caregivers (CG)
- Active primary caregiver of a Person with Dementia (PwD) for at least 6 months and planning to remain the primary caregiver for the next 2 months
- Currently living with the PwD
- CG plans to live in the area for the duration of the study
- Is familiar and comfortable utilizing technology (e.g. computers, tablets, the internet)
Persons with Dementia (PwD)
- CG reports that the PwD exhibits at least one or more behavioral symptoms (any behavior at any frequency)
- PwD receiving psychotropic medication or cognitive enhancers will not be excluded.
- If PwD is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that he/she have been on a stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications.
- Clinical diagnosis of dementia (any type) or a score of less than 24 on the Mini-Mental State Examination (MMSE)
Exclusion Criteria:
General
- Inability to read, speak or understand English
- Home location greater than 50 miles from the study site
- Lack of regular access to a telephone Caregivers (CG)
- Reading literacy of less than 6th grade
- Visual impairment to the extent of prohibiting interaction with the tool
- Hearing impairment sufficient to prohibit telephone communication
- Other self-identified mental or physical health issues that would distinctly interfere with the ability to reasonably test the tool or complete behavioral interventions (e.g. substance use disorder, schizophrenia, severe mobility issues)
- Hospitalized more than 3 times in the past year
- Participating in another study to help caregivers care for the person with dementia.
Persons with Dementia (PwD)
- At a terminal phase of illness, unable to respond to the environment or with a life expectancy less than 6 months
- Active suicide risk
- Imminent placement to nursing home (within the next 60 days)
- Hospitalized more than 3 times in the past year
- Currently in another study testing a medication to control behavioral symptoms
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Immediately Receive Tool
Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks.
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有源比较器:One Month Delay
Caregiver/Care Recipient Dyad will be randomly assigned to a 4 week delay (usual care activities only) before receiving the WeCareAdvisor Tool for 4 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 |
|---|---|---|
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Effects of the WeCareAdvisor Tool on Caregiver Upset
大体时间:4 weeks
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We will measure caregiver upset on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
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4 weeks
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Effect of the WeCareAdvisor Tool on Caregiver Confidence
大体时间:4 weeks
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We will measure caregiver confidence on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
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4 weeks
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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。
调查人员
- 首席研究员:Helen Kales, MD、University of Michigan
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。
一般刊物
- Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
- Kales HC, Gitlin LN, Stanislawski B, Myra Kim H, Marx K, Turnwald M, Chiang C, Lyketsos CG. Effect of the WeCareAdvisor on family caregiver outcomes in dementia: a pilot randomized controlled trial. BMC Geriatr. 2018 May 10;18(1):113. doi: 10.1186/s12877-018-0801-8.
- Gitlin LN, Kales HC, Marx K, Stanislawski B, Lyketsos C. A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor. Contemp Clin Trials. 2017 Nov;62:27-36. doi: 10.1016/j.cct.2017.08.001. Epub 2017 Aug 9.
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5月1日
初级完成 (实际的)
2016年10月1日
研究完成 (实际的)
2016年10月1日
研究注册日期
首次提交
2015年4月14日
首先提交符合 QC 标准的
2015年4月14日
首次发布 (估计)
2015年4月20日
研究记录更新
最后更新发布 (估计)
2016年12月19日
上次提交的符合 QC 标准的更新
2016年12月15日
最后验证
2016年12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.
Immediately Receive Tool的临床试验
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Necmettin Erbakan UniversityKonya City Hospital招聘中