Clinical trial NCT04992286: Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING)
Official title: Detection, Evaluation and Monitoring of Frailties in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Keywords: Elderly
Community-dwelling
Screening
Prevention
Health
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Université d'Auvergne
name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2021-08-05
Enrollment: 800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all participants receive the same intervention
Primary purpose: SCREENING

Brief summary: 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

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Medico-economic relevance of early detection of frailty through a day dedicated to this theme organized in a rural and semi-urban area
timeFrame: Baseline
measure: Evaluation of precarity
timeFrame: Baseline
measure: Evaluation of psychological aspect
timeFrame: Baseline
measure: Evaluation of quality of life
timeFrame: Baseline
measure: Evaluation of caregiver
timeFrame: Baseline
measure: 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).
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.
timeFrame: Baseline
measure: Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.
timeFrame: Baseline
measure: Prevalence of the rate of organized cancer screening among people aged 65 or more in the Mauriac and Vichy community health regions.
timeFrame: Baseline
measure: Prevalence of the rate of risky alcohol consumption among people aged 65 or more in the Mauriac and Vichy community health regions.
timeFrame: Baseline
measure: Prevalence of participants with a high cardiovascular risk factor among people aged 65 or more in the Mauriac and Vichy community health regions.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: To measure physical activity levels of 65 years or older in a rural and a semi-urban population
timeFrame: Baseline
measure: To measure physical inactivity levels of 65 years or older in a rural and a semi-urban population
timeFrame: Baseline
measure: Modeling the flow of screened and identified frail participants who will be managed by type of frailty identified
timeFrame: Baseline
measure: Modeling the flow of screened and identified frail participants who will be managed by type of frailty identified (monte Carlo microstimulation)
timeFrame: Baseline
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine Duclos
role: PRINCIPAL_INVESTIGATOR
References: