NCT04941222终止不适用
Cost-utility Analysis of the Use of the Paro Robotic Seal by Elderly Patients With Moderate or Severe Cognitive Disorders in Institutions: a Randomised Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Incremental cost-utility ratio
研究概览
简要总结
Many residents from establishments for dependent elderly people (EHPAD) have memory disorders with behavioural problems such as agitation, aggression and anxiety, which make it difficult to assist them on a daily basis.
Studies have proven the beneficial effect of the therapeutic seal robot PARO® in behavioural disorders. The present project aims to complement these data with a medico-economic study. At present, the only study of this type has been carried out in Australia, and is not transposable to France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 70 years of age
- •With moderate or severe neurocognitive disorders of any etiology (Mini Mental State Examination (MMSE) less than or equal to 20, or not feasible)
- •Resident in EHPAD (establishment for dependent elderly people) or USLD (long-term care unit ) in permanent accommodation for more than 1 month at inclusion
排除标准
- •Patient with presumed life expectancy of less than 3 months
- •Mini Mental State Examination (MMSE) not feasible for any reason other than cognitive impairment (e.g. stroke aphasia), without dementia
- •Known carrier of multi-drug resistant bacteria
- •Carrier of Pace-maker (precautionary advice from manufacturer)
- •Refusal to participate to the study (trusted person, guardian or curator or patient depending on the patient's mental state)
- •Patient under court protection
- •Prior inclusion in an interventional study that may alter the interpretation of the results of the analysis
- •Patient not affiliated to a social security system or beneficiary of such a system
结局指标
主要结局
Incremental cost-utility ratio
时间窗: 16 weeks after implementation of toilets with/without PARO
Incremental cost-utility ratio (cost/QALY) from a societal perspective and a time horizon of 16 weeks of the use of the PARO robot
次要结局
未报告次要终点
研究者
研究点 (2)
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