Effects and Costs of a Day Care Centre Program Designed for People With Dementia (ECOD)
2020年2月7日 更新者：Norwegian Centre for Ageing and Health
Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study
Attending day care centres with programs specifically designed for patients with dementia is believed to postpone admittance to nursing home as well as increase quality of life and well-being for both patients and their family caregivers.
We aim to investigate to what degree attendance in day care centres with programs for people with dementia is effective for patient and their caregivers whilst also cost efficient for society.
The study consists of a quasi-experimental trial with comparison group.
400 patients with dementia, along with a family caregiver, will be included in the trial.
Effects will be measured at baseline, after one and two years.
Data collection will be made at three levels; at patient level with measures of cognition, depression, quality of life, functioning in activities in daily living, neuropsychiatric symptoms and death; at caregiver level with measures of depression, level of burden and quality of life; and at societal level with measures of nursing home admittance, hospital stays and use of other health resources.
Additionally,a qualitative interview study will include 20 dyads from the main trial.
The main focus will be on how attending day care centre programs for patients with dementia affect the lives of both patients and caregivers.
Five of these dyads will be followed closely throughout the participation period to be used as case examples.
研究概览
详细说明
A quasi experimental trial with a comparison group will be performed to evaluate the effect of the day care centre programs by comparing results from municipalities with (intervention group) and without (comparison group) a day care centre program designed for people with dementia using standardized assessment tools.
Furthermore, a survey will be used to explore the communication and co-operation between the professional staff at the day care centre, the patients and the family carers by administering questionnaires to all three parties.
Only patients with mild degree of dementia will be asked to participate in the questionnaire.
Finally, qualitative interviews will be made with 20 dyads of patients and family carers to collect their in depth experience with the day care centre program.
Five of these patients and their family carers will be followed closely as case examples for two years.
研究类型
介入性
注册 (实际的)
261
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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Tønsberg、挪威、3103
- Norwegian centre of Ageing and Health
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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
65年 及以上 (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:
- Age of 65 years or more and living at home
- Patients in the day care centre group must have attended the centre for at least four weeks and have been there no longer than nine months
- Dementia of either Alzheimer's type, vascular dementia, dementia with Lewy bodies/Parkinson's disease or a mixture of these types of dementias
- Capacity to give informed consent as judged by the professional caregivers
- A Mini Mental Status Examination (MMSE) score of ≥15
- Having a family carer willing to participate, who see the patients personally at least once a week
- Attending the day care centre program at least twice a week
Exclusion Criteria:
- Having applied for nursing home placement
- Suffering from a serious co-morbid physical disorder with life expectancy less than six 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：卫生服务研究
- 分配：非随机化
- 介入模型：并行分配
- 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：Day care for patients with dementia
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Day care centres designed by the local authorities for patients with dementia
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无干预：一如既往的关怀
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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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Admittance to nursing home care
大体时间：24 months
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The number of patients admitted to nursing home care during a period of 24 months will be the primary outcome for the effect and the cost-consequence analysis
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24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Quality of life for patients
大体时间：12 and 24 months
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The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
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12 and 24 months
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Change in the patient's functioning of daily living
大体时间：12 and 24 months
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The Physical self-Maintenance Scale and Instrumental Activities of Daily Living Scale will be used to assess change in the patient's function of daily living
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12 and 24 months
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Change in depressive symptoms in patients
大体时间：12 and 24 months
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The change in depressive symptoms will be assessed by Montgomery Asberg Depression Rating Scale (MADRS)by interviews with both patient and family carer and the Cornell Scale for Depression in Dementia (CSDD) by interviews with family carers and a professional caregiver
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12 and 24 months
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Change in patient's cognition
大体时间：12 and 24 months
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Patient's cognition will be assessed using the Mini Mental State Examination (MMSE) the Clock Drawing Test (CDT), the Trail Making Test A (TMT-A)and the 10 word test of the Consortium to Establish a Registry in Alzheimer's Disease (CERAD)
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12 and 24 months
|
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Change in neuropsychiatric symptoms in patients
大体时间：12 and 24 months
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The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
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12 and 24 months
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Patients death
大体时间：24 months
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Number of patients that have died during 24 months will be registered
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24 months
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Change in level of burden in family carers
大体时间：12 and 24 months
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Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)
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12 and 24 months
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Change in family carers depressive symptoms
大体时间：12 and 24 months
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The MADRS will be used to assess depressive symptoms in family carers
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12 and 24 months
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Change in quality of life for family carers
大体时间：12 and 24 months
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QoL-AD will be used to assess quality of life in family carers
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12 and 24 months
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Differences in the use of health resources between the intervention group and the control group
大体时间：12 and 24 months
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The use of health resources will be measured using the resource Utilization in Dementia scale (RUD)
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12 and 24 months
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Differences in quality adjusted life years between the intervention group and the control group
大体时间：12 and 24 months
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A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
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12 and 24 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。
调查人员
- 学习椅：Knut Engedal, Professor、Norwegian Centre for Ageling and health
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 (实际的)
2013年8月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月31日
研究注册日期
首次提交
2013年9月11日
首先提交符合 QC 标准的
2013年9月11日
首次发布 (估计)
2013年9月16日
研究记录更新
最后更新发布 (实际的)
2020年2月10日
上次提交的符合 QC 标准的更新
2020年2月7日
最后验证
2020年2月1日
更多信息
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