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临床试验/NCT02155686
NCT02155686已完成不适用

Etude de l'Impact Clinique de la télésurveillance à Domicile Par télémédecine de paramètres biométriques de la Personne âgée Polypathologique

University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2014年8月27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
发起方
入组人数
536
试验地点
1
主要终点
Number of unplanned hospitalization for decompensation

研究概览

简要总结

The elderly or people with disabilities want to remain in their homes even when their health condition has been getting worse.

This project aims to demonstrate that home automation and telemonitoring can lead to develop a home safety environment that could help the elderly and individual with disability live independently in their own home.

In this study, the automation sensors containing devices follow up chronic disease clinical factors to monitor their biometrical parameters and detect any abnormal prodromal disease decompensation via telemonitoring and geriatric expertise.

The purpose of this study is:

  • to provide clinical evidence of the effectiveness of automation tools and telemonitoring/expertise for the home support for people at risk of loss of autonomy
  • to demonstrate the clinical benefit of combining the automation and telemonitoring and geriatric teleexpertise

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Aged 65 or more.
  • House equipped with home automation
  • Having been hospitalized in the year prior to the inclusion for the following conditions : heart failure, chronic obstructive pulmonary disease (COPD ), diabetes, high blood pressure ( hypertension ) , repetitive falls, chronic renal failure , stroke, neurodegenerative diseases , malnutrition (according to criteria HAS)
  • Multiple chronic diseases (at least 2 comorbidities) .
  • Having given free and informed consent

排除标准

  • Life expectancy less than 12 months
  • Enrolled in another clinical trial

研究组 & 干预措施

Biosensors

Experimental

Participants in this arm are equipped both with home telecare/automation and with biometric sensors

干预措施: Biosensors (Device)

Biosensors

Experimental

Participants in this arm are equipped both with home telecare/automation and with biometric sensors

干预措施: Home automation (Device)

Automation

Active Comparator

Participants in this arm are equiepd with home automation only

干预措施: Home automation (Device)

结局指标

主要结局

Number of unplanned hospitalization for decompensation

时间窗: at 12 months

The effectiveness of home telemonitoring on the cumulative incidence of unplanned hospitalization for decompensation in the elderly

次要结局

  • Impact on global health(at 12 months)
  • Cost/effectivness preventive care(at 12 months)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (1)

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