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

31 januari 2023 bijgewerkt door: 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

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Verwacht)

800

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

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

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

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

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 september 2021

Primaire voltooiing (Werkelijk)

11 november 2022

Studie voltooiing (Verwacht)

1 juni 2023

Studieregistratiedata

Eerst ingediend

28 juni 2021

Eerst ingediend dat voldeed aan de QC-criteria

29 juli 2021

Eerst geplaatst (Werkelijk)

5 augustus 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 februari 2023

Laatste update ingediend die voldeed aan QC-criteria

31 januari 2023

Laatst geverifieerd

1 januari 2023

Meer informatie

Termen gerelateerd aan deze studie

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

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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