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Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING) (FRAGING)

2023년 1월 31일 업데이트: University Hospital, Clermont-Ferrand

Detection, Evaluation and Monitoring of Frailties in the Elderly

The aging of the French population is a major public health issue. Frailty is a reversible clinical state between optimal healthy aging and pathological aging. Early detection of frailty makes it possible to identify people aged 65 or over who are at risk of developing or worsen dependency and to offer them appropriate medical and/or social care adapted to their needs. The multidimensional screening program known as "ICOPE" (for "Integrated Care of Older People") promoted by the World Health Organization (WHO) aims to prevent functional decline worldwide and improve the well-being of older people. To support healthy aging, 6 intrinsic abilities are to be screened according to ICOPE: visual impairment, hearing impairment, depressive symptoms, locomotor abilities, cognitive decline and vitality. This program is intended to be developed in each country and adapted to the territories of action. The Mauriac and Vichy community health basins have a proportion of elderly people (≥60 years old) that is much higher than regional and national data, justifying the regional and national data, justifying the chosen action territories. The epidemiological characteristics of the French population and of the action territory made it possible to add to the following themes to the ICOPE recommendations: socio-economic situation, assistance to caregivers, vaccinations, drug iatrogeny, alcohol consumption, cardiovascular risk and cancer screening. The ICOPE process is organized in 5 steps: a community screening and a relay to the general practitioner to ensure a follow-up, an primary care in case of abnormality, evaluated at 3 months and then 6 months, establishment of a plan of care if necessary, possible referral to a specialist and mobilization of community resources mobilization of community resources and support for caregivers if needed.

The hypothesis is that conducting a fragility screening in a rural area (Mauriac health (Mauriac health basin) and a semi-urban area (Vichy health basin) would allow an effective would allow an effective allocation of expenses. In more detail, the costs are direct medical, direct non-medical, indirect and intangible costs, and efficiency is measured by measured by the quality of life score (LEIPAD). The hypothesis is that the early detection of people's frailties and their management improves their quality of life

연구 개요

상태

모집하지 않고 적극적으로

정황

상세 설명

Prior to the frailty screening days, information letter will be sent to the people living in the territories of action in order to present them the project. The evaluation of the level of frailty will be done in 3 steps: an inclusion visit with one of the co-investigating physicians or one of the scientific collaborators. The investigating physician will verify the eligibility criteria (inclusion and non-inclusion criteria), and will propose to the person to participate in the protocol (consent). Individuals will also have the option to participate in the screening day but refuse to sign the sheet attesting to their consent, in which case none of the data concerning them will be kept and analyzed. After consent has been obtained, individuals will be instructed to participate in the questionnaire (M0), the frailty screening visit (M0), to the analysis of medical prescriptions (M0), to a debriefing visit (M0), and a follow-up telephone visit for people detected as frail (M3, M6). For 10 volunteers per screening day, a visit to present the accelerometers will also be added (M0), as well as an assessment of physical activity assessment (+7 days).

연구 유형

중재적

등록 (예상)

800

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Clermont-Ferrand, 프랑스, 63000
        • CHU de Clermont-Ferrand

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

65년 이상 (고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Person, man or woman, aged 65 years or more, who came to attend a day dedicated to the theme organized within the CPTS of Mauriac or Vichy by medical medical, paramedical, medico-social professionals and cultural and sports and sports associations.
  • Living in the Mauriac or Vichy health basin.
  • Able to give informed consent to participate in the research.
  • Affiliation to a Social Security system.

Exclusion Criteria:

  • People who have a pathological aging defined by a chronic disease chronic disease covered by the Long Term Affection (ALD).
  • Persons under guardianship or curatorship.
  • Refusal to participate in the study expressed by the person.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: people aged 65 years or more
men or women, age Superior to 65 years
questionnaire to evaluate fragility
To evaluate physical activity level

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Medico-economic relevance of early detection of frailty through a day dedicated to this theme organized in a rural and semi-urban area
기간: Baseline
The costs include direct medical costs (costs of screening for frailty, post-screening management, avoided by early management); direct non-medical costs (out of pockets); indirect costs (caregiver opportunity costs) measured in euros
Baseline
Evaluation of precarity
기간: Baseline
measured by the Evaluation of Precarity and Inequalities of Health in Health Examination Centers (EPICES) score (min: 0-max: 100; lower scores referring to good conditions, 30=threshold of precarity),
Baseline
Evaluation of psychological aspect
기간: Baseline
measured by the psychological aspect measured by the dedicated questionnaire (PHQ-9) (min: 0-max: 27; lower scores referring to good conditions),
Baseline
Evaluation of quality of life
기간: Baseline
measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions)
Baseline
Evaluation of caregiver
기간: Baseline
measured by the caregiver questionnaire (MiniZarit) . (min: 0-max: 7; lower scores referring to good conditions)
Baseline
Medico-economic relevance of early detection of frailty through a day dedicated to this theme organized in a rural and semi-urban area (Cost effectiveness).
기간: Baseline
Effectiveness is measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions).
Baseline

2차 결과 측정

결과 측정
측정값 설명
기간
Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.
기간: Baseline
measured in pourcent (%)
Baseline
Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.
기간: Baseline
measured in pourcent (%)
Baseline
Prevalence of the rate of organized cancer screening among people aged 65 or more in the Mauriac and Vichy community health regions.
기간: Baseline
measured in pourcent (%)
Baseline
Prevalence of the rate of risky alcohol consumption among people aged 65 or more in the Mauriac and Vichy community health regions.
기간: Baseline
measured in pourcent (%)
Baseline
Prevalence of participants with a high cardiovascular risk factor among people aged 65 or more in the Mauriac and Vichy community health regions.
기간: Baseline
measured in pourcent (%)
Baseline
Identify the determinants of frailty (physical, psychological, and associated factors) in people aged 65 years or more in a rural and a semi-urban population.
기간: Baseline
measured by physical examination by physician
Baseline
To measure physical activity levels of 65 years or older in a rural and a semi-urban population
기간: Baseline
measured by the questionnaire (ONAPS-Q) and by accelerometer (MET.minutes/week)
Baseline
To measure physical inactivity levels of 65 years or older in a rural and a semi-urban population
기간: Baseline
measured by - sedentary time measured by the questionnaire (ONAPS-Q) and by accelerometer (minutes per day) (no scale)
Baseline
Modeling the flow of screened and identified frail participants who will be managed by type of frailty identified
기간: Baseline
- Categorization of the health pathways followed by the study cohort (no unit of measure)
Baseline
Modeling the flow of screened and identified frail participants who will be managed by type of frailty identified (monte Carlo microstimulation)
기간: Baseline
measured by - Monte Carlo micro-simulation that will model the flows of participants (no unit of measure)
Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 9월 7일

기본 완료 (실제)

2022년 11월 11일

연구 완료 (예상)

2023년 6월 1일

연구 등록 날짜

최초 제출

2021년 6월 28일

QC 기준을 충족하는 최초 제출

2021년 7월 29일

처음 게시됨 (실제)

2021년 8월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2023년 2월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2023년 1월 31일

마지막으로 확인됨

2023년 1월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RBHP 2021 DUCLOS 2
  • 2021-A00367-34 (기타 식별자: ANSM)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

questionnaire에 대한 임상 시험

구독하다