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

31 de janeiro de 2023 atualizado por: 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

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Antecipado)

800

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

65 anos e mais velhos (Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Triagem
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: people aged 65 years or more
men or women, age Superior to 65 years
questionnaire to evaluate fragility
To evaluate physical activity level

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Medico-economic relevance of early detection of frailty through a day dedicated to this theme organized in a rural and semi-urban area
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline
measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions)
Baseline
Evaluation of caregiver
Prazo: 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).
Prazo: Baseline
Effectiveness is measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions).
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.
Prazo: Baseline
measured in pourcent (%)
Baseline
Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: Baseline
measured by - Monte Carlo micro-simulation that will model the flows of participants (no unit of measure)
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

7 de setembro de 2021

Conclusão Primária (Real)

11 de novembro de 2022

Conclusão do estudo (Antecipado)

1 de junho de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

28 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de julho de 2021

Primeira postagem (Real)

5 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de fevereiro de 2023

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de janeiro de 2023

Última verificação

1 de janeiro de 2023

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RBHP 2021 DUCLOS 2
  • 2021-A00367-34 (Outro identificador: ANSM)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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