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临床试验/NCT02518243
NCT02518243已完成不适用

Safe & Easy for Alzheimer's Disease and Related Pathologies

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire

研究概览

简要总结

All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

详细描述

The non pharmacological therapeutic will be install at hospital room :

  • aromatherapy,
  • music therapy,
  • cognitive training in multimedia application offering cognitive games.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007).
  • Score at Mini Mental Test (MMSE) ≥
  • Subjects residing in nursing homes.
  • Subjects beneficiaries of a social security scheme.
  • Signature of free and informed consent.

排除标准

  • Failure to pass the neuropsychological tests because of a sensory or motor deficit.
  • Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions.
  • Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation;
  • Persons deprived of liberty (administrative or judicial).

结局指标

主要结局

Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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