Seamless Follow up and Support System for Frail Elderly Living at Home (FRAGIL-IT)
FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home
研究概览
详细说明
Functional decline challenges the sustainability of healthcare systems. There are difficulties in implementing effective interventions to prevent disability, to promote adherence to lifestyle recommendations and to perform seamless follow-up at home. A technological solution addressing this challenge and improving individual participation would be welcome. Our aim is to evaluate an instrument for supporting physical activity and monitoring multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigator and collaborator are therefore developing a solution to monitor key parameters of frailty during subject daily life and to promote walking. This tools are :
- connected soles to evaluate different parameters of the volunteer walking
- connected weighing machine to evaluate the volunteer weight and equilibrate
- machine to measure gripping force because gripping force is correlated to physical condition.
The primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients 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 efficiency of the solution to prevent disability.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Midi-Pyrenes
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Toulouse、Midi-Pyrenes、法国、31059
- University Hospital, Toulouse
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patient living at home;
- pre-frail or frail volunteers;
- Informed and written consent by the patient or the legal representative or the reliable person when appropriate.
Exclusion Criteria:
- patient's life expectancy less than 12 months; patient presenting disability with an Activity of Daily Living score < 4/6 ant/or a Mini - Mental State <20/30, not walking or walking with a technical support;
- Non agreement of study participation of patients or legal representative or the reliable person when appropriate.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：FRAGIL-IT testing group
FRAGIL-IT tools : connected soles, connected weighting machine and measure of gripping force
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Volunteer must walk this this connected seamless to measure different walking parameters
其他名称：
This weighting machine measure weight evolution and equilibrate of volunteers
其他名称：
this machine measure the gripping force of volunteer
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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acceptability of FRAGIL-IT tools
大体时间：3 months
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primary outcome is based on the acceptability of the FRAGIL-IT tools for the end-user : connected soles, connected weighting machine and measure of gripping force to control autonomy loss.
The acceptability of this tools will be evaluate by questionnaire as The Short Form (36) Health Survey (SF36) questionnaire
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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evaluation of life quality with SF36 questionnaire
大体时间：3 months
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the life quality will be assess with SF36 questionnaire
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3 months
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functional status measure by ADL
大体时间：3 months
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functional status will be assess with Activity of Daily Living (ADL) score.
The scale of ADL is between 0 to 6. 0 is worse than 6.
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3 months
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functional status measure by iADL
大体时间：3 months
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functional status will be assess with instrumental Activity of Daily Living (iADL) score.
The scale of IADL is between 0 to 8. 0 is worse than 8.
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3 months
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cognitive status
大体时间：3 months
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cognitive status will be assess with Mini Mental State (MMS)
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3 months
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合作者和调查者
调查人员
- 首席研究员：Antoine PIAU, MD、University Hospital, Toulouse
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.