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临床试验/NCT03484156
NCT03484156已完成不适用

Predictive Platform for PEople aGed and Requiring ASsistancE

University Hospital, Toulouse4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
4
主要终点
The occurrence of alerts

研究概览

简要总结

The study aim is to assess the capacity of a technological solution for analyzing older person's functional and cognitive autonomy at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to detect early infra-clinical disability.

详细描述

The object of the present project is to evaluate an instrument for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home. By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss. The device consists of a set of sensors embedded in the house with minimal invasiveness. The solution transmits the collected data to a remote storage server. Data will then be available for distance consultations by users (i.e., patients, careers or physicians). The study will conduct a wide range of evaluations of the device (technical, clinical, and economic), which will allow the optimization of the prototype. The evaluation of the solution will involve 25 frail or disable community-dwelling subjects living alone for 6 months. Comprehensive assessments will be conducted to highlight the feasibility, integration in healthcare network, and clinical relevance of the technological device.

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
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient aged 75 or more, living alone at home
  • frail of disable (ADL superior or equal at 3)
  • able to walk by themselves

排除标准

  • patient presenting a Mini Mental State lower at 16/30 and without a daily intervention from a caregiver
  • non agreement of study participation of patients or the reliable person when appropriate.

研究组 & 干预措施

Volunteers

Experimental

The Installation of 3PEGASE Sensor in elders volunteers to monitor clinical indicators at home.The instrument is for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home.

The volunteers will have 70 years old or more, living alone at home, frail of disable (ADL> or =3) and able to walk by themselves.

干预措施: Installation of 3PEGASE Sensor (Device)

结局指标

主要结局

The occurrence of alerts

时间窗: 6 months

The occurrence of alerts : each alert will be recorded to characterize the number and the pace of alerts during the time of follow-up

次要结局

  • The relevance of each alert according to the subjective opinion(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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