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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Midi-Pyrenes
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Toulouse、Midi-Pyrenes、フランス、31059
- University Hospital, Toulouse
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
他の名前：
This weighting machine measure weight evolution and equilibrate of volunteers
他の名前：
this machine measure the gripping force of volunteer
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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acceptability of FRAGIL-IT tools
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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evaluation of life quality with SF36 questionnaire
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Antoine PIAU, MD、University Hospital, Toulouse
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。