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

31 de enero de 2023 actualizado 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

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Descripción detallada

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 estudio

Intervencionista

Inscripción (Anticipado)

800

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: people aged 65 years or more
men or women, age Superior to 65 years
questionnaire to evaluate fragility
To evaluate physical activity level

¿Qué mide el estudio?

Medidas de resultado primarias

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

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de septiembre de 2021

Finalización primaria (Actual)

11 de noviembre de 2022

Finalización del estudio (Anticipado)

1 de junio de 2023

Fechas de registro del estudio

Enviado por primera vez

28 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

29 de julio de 2021

Publicado por primera vez (Actual)

5 de agosto de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de febrero de 2023

Última actualización enviada que cumplió con los criterios de control de calidad

31 de enero de 2023

Última verificación

1 de enero de 2023

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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