- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Clermont-Ferrand, Frankrijk, 63000
- CHU de Clermont-Ferrand
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: people aged 65 years or more
men or women, age Superior to 65 years
|
questionnaire to evaluate fragility
To evaluate physical activity level
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Medico-economic relevance of early detection of frailty through a day dedicated to this theme organized in a rural and semi-urban area
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
|
measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions)
|
Baseline
|
|
Evaluation of caregiver
Tijdsspanne: 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).
Tijdsspanne: Baseline
|
Effectiveness is measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions).
|
Baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.
Tijdsspanne: Baseline
|
measured in pourcent (%)
|
Baseline
|
|
Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Baseline
|
measured by - Monte Carlo micro-simulation that will model the flows of participants (no unit of measure)
|
Baseline
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RBHP 2021 DUCLOS 2
- 2021-A00367-34 (Andere identificatie: ANSM)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .