跳至主要内容
临床试验/NCT01697553
NCT01697553终止不适用

Home-Based Technologies Coupled to Teleassistance Service: Efficacy for Preventing Falls at Home in Frail Elderly Population Losing Autonomy

University Hospital, Limoges8 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2012年10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
终止
发起方
入组人数
27
试验地点
8
主要终点
incidence of home falls requiring emergency admission

研究概览

简要总结

The growth of the elderly population is associated with the autonomy failure and the increase of dependence problems. Fall incidents are the third cause of chronic disablement in older persons and are one of the major risk factors for entering in dependence.

The recent progress in home technologies and medical care are opportunities to search how to apply these tools to reduce and prevent falling at home.

The purpose of this study is to evaluate the cost effectiveness of simple home automation pack coupled to teleassistance service for preventing home falls in frail elderly population.

1200 patients will be enrolled and randmosied within two arms:

  • home with automation pack coupled to teleassistance service
  • home without this technology

详细描述

This study is one of the first European randomized studies using the criteria MAST (Model for Assessment of Telemedicine) for medico-economic evaluation of technology solutions for the prevention and care in the elderly. The medico-economic evaluation of the overall contribution of home automation kit associated with telecare will be conducted in accordance with the recommendations of the research program Renewing Health FP7 the European Union. This program has developed an analytical model common to all evaluations of telemedicine applications that have an impact on health.

. The home-based technology in this study will be a simple home automation pack coupled to teleassistance service. The automation pack will include: a remote intercom, an electronic bracelet or pendentive, a pull shower in the bathroom, a light path, a smoke detector and a gas detector in the kitchen. The central hotline will provide telephone support at all times.

Intercom is a remote transmitter which enables the platform to provide remote assistance with the elderly at home.

Each person will have electronic bracelet or pendentive with a medallion which will be provided with the dialer. It is a system that allows remote assistance to the elderly by pressing the central medallion of the device to request assistance or report a dangerous situation (risk of falling, or fall) to the platform of teleassistance.

The bathroom alarm zipper is a device installed in the shower that allows subjects to use it when at risk of falling or fall detection. The shower is a high risk of fall for the elderly due to movements very often results in an imbalance of seniors already weakened by aging.

研究设计

研究类型
Interventional
分配方式
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

  • Patient aged 65 or over
  • Living at least for 1 year in the department of Creuse
  • Frail elderly or pre-frail according to the criteria of Fried
  • Patient with autonomy enough to get out of bed
  • Having a cognitive level acceptable (MMS ≥ 10)
  • Place of life arranged and adapted to the installation of the DSTA
  • Consentbsigned by the patient and / or its trusted person or his legal representative
  • Affiliation or beneficiary of a social security system

排除标准

  • Patient under guardianship or protection of justice
  • patient home already equiped with automation pack different from theone of the experiment
  • People who can not read or write
  • Diseases involving life-threatening in the short term (<1 year)

研究组 & 干预措施

Home automation pack coupled to teleassistance service

Experimental

干预措施: home automation pack coupled to teleassistance service (Other)

Home without automation pack coupled to teleassistance service

Active Comparator

干预措施: Home without automation pack coupled to teleassistance service (Other)

结局指标

主要结局

incidence of home falls requiring emergency admission

时间窗: at 12 months

The cumulated incidence of home falls requiring emergency admission.

次要结局

  • Changes score ISO profile resource according to SMAF scale(at 12 months)
  • Proportion of participants with regular physical activity(at 12 months)
  • Effect on admissions in institutions (nursing homes or senior residential care)(at 12 months)
  • Time before management of stroke and the length of stay in rehabilitation unit(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 (8)

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