- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04992286
Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING) (FRAGING)
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
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Clermont-Ferrand, Francia, 63000
- CHU de Clermont-Ferrand
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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