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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Midi-Pyrenes
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Toulouse, Midi-Pyrenes, 프랑스, 31059
- University Hospital, Toulouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
다른 이름들:
This weighting machine measure weight evolution and equilibrate of volunteers
다른 이름들:
this machine measure the gripping force of volunteer
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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acceptability of FRAGIL-IT tools
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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evaluation of life quality with SF36 questionnaire
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Antoine PIAU, MD, University Hospital, Toulouse
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .