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临床试验/NCT01943071
NCT01943071已完成不适用

Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study

Norwegian Centre for Ageing and Health2 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
261
试验地点
2
主要终点
Admittance to nursing home care

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Having applied for nursing home placement
  • Suffering from a serious co-morbid physical disorder with life expectancy less than six months

结局指标

主要结局

Admittance to nursing home care

时间窗: 24 months

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

次要结局

  • Differences in the use of health resources between the intervention group and the control group(12 and 24 months)
  • Change in depressive symptoms in patients(12 and 24 months)
  • Change in patient's cognition(12 and 24 months)
  • Change in quality of life for family carers(12 and 24 months)
  • Change in neuropsychiatric symptoms in patients(12 and 24 months)
  • Change in family carers depressive symptoms(12 and 24 months)
  • Differences in quality adjusted life years between the intervention group and the control group(12 and 24 months)
  • Change in the patient's functioning of daily living(12 and 24 months)
  • Patients death(24 months)
  • Change in level of burden in family carers(12 and 24 months)
  • Change in Quality of life for patients(12 and 24 months)

研究者

发起方
Norwegian Centre for Ageing and Health
申办方类型
Other
责任方
Sponsor

研究点 (2)

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