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

Frailty Clinical Trial

— FRAGING  

Official title:

Detection, Evaluation and Monitoring of Frailties in the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04992286
• Other study ID #: RBHP 2021 DUCLOS 2
• Secondary ID: 2021-A00367-34
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: June 2023
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• questionnaire
questionnaire to evaluate fragility
• accelerometer
To evaluate physical activity level

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medico-economic relevance of early detection of frailty through a day dedicated to this theme organized in a rural and semi-urban area	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
Primary	Evaluation of precarity	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
Primary	Evaluation of psychological aspect	measured by the psychological aspect measured by the dedicated questionnaire (PHQ-9) (min: 0-max: 27; lower scores referring to good conditions),	Baseline
Primary	Evaluation of quality of life	measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions)	Baseline
Primary	Evaluation of caregiver	measured by the caregiver questionnaire (MiniZarit) . (min: 0-max: 7; lower scores referring to good conditions)	Baseline
Primary	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).	Effectiveness is measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions).	Baseline
Secondary	Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.	measured in pourcent (%)	Baseline
Secondary	Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.	measured in pourcent (%)	Baseline
Secondary	Prevalence of the rate of organized cancer screening among people aged 65 or more in the Mauriac and Vichy community health regions.	measured in pourcent (%)	Baseline
Secondary	Prevalence of the rate of risky alcohol consumption among people aged 65 or more in the Mauriac and Vichy community health regions.	measured in pourcent (%)	Baseline
Secondary	Prevalence of participants with a high cardiovascular risk factor among people aged 65 or more in the Mauriac and Vichy community health regions.	measured in pourcent (%)	Baseline
Secondary	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.	measured by physical examination by physician	Baseline
Secondary	To measure physical activity levels of 65 years or older in a rural and a semi-urban population	measured by the questionnaire (ONAPS-Q) and by accelerometer (MET.minutes/week)	Baseline
Secondary	To measure physical inactivity levels of 65 years or older in a rural and a semi-urban population	measured by - sedentary time measured by the questionnaire (ONAPS-Q) and by accelerometer (minutes per day) (no scale)	Baseline
Secondary	Modeling the flow of screened and identified frail participants who will be managed by type of frailty identified	- Categorization of the health pathways followed by the study cohort (no unit of measure)	Baseline
Secondary	Modeling the flow of screened and identified frail participants who will be managed by type of frailty identified (monte Carlo microstimulation)	measured by - Monte Carlo micro-simulation that will model the flows of participants (no unit of measure)	Baseline