- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Clermont-Ferrand, Francia, 63000
- CHU de Clermont-Ferrand
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: people aged 65 years or more
men or women, age Superior to 65 years
|
questionnaire to evaluate fragility
To evaluate physical activity level
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Medico-economic relevance of early detection of frailty through a day dedicated to this theme organized in a rural and semi-urban area
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
|
measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions)
|
Baseline
|
|
Evaluation of caregiver
Lasso di tempo: 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).
Lasso di tempo: Baseline
|
Effectiveness is measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions).
|
Baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.
Lasso di tempo: Baseline
|
measured in pourcent (%)
|
Baseline
|
|
Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Baseline
|
measured by - Monte Carlo micro-simulation that will model the flows of participants (no unit of measure)
|
Baseline
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RBHP 2021 DUCLOS 2
- 2021-A00367-34 (Altro identificatore: ANSM)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .