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

NCT04992286 | Unknown

• 2 other identifiers: RBHP 2021 DUCLOS 22021-A00367-34
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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

Conditions

Frailty

Keywords

Elderly; Community-dwelling; Screening; Prevention; Health

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Evaluation of quality of life

  measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions)

  Baseline

• Evaluation of caregiver

  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).

  Effectiveness is measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions).

  Baseline

Secondary Outcomes (10)

• Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.

  Baseline

• Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.

  Baseline

• Prevalence of the rate of organized cancer screening among people aged 65 or more in the Mauriac and Vichy community health regions.

  Baseline

• Prevalence of the rate of risky alcohol consumption among people aged 65 or more in the Mauriac and Vichy community health regions.

  Baseline

• Prevalence of participants with a high cardiovascular risk factor among people aged 65 or more in the Mauriac and Vichy community health regions.

  Baseline

Study Arms (1)

people aged 65 years or more

EXPERIMENTAL

men or women, age Superior to 65 years

Other: questionnaire; Other: accelerometer

Interventions

questionnaire OTHER

questionnaire to evaluate fragility

people aged 65 years or more

accelerometer OTHER

To evaluate physical activity level

people aged 65 years or more

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Université d'Auvergne: collaborator
• Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Frailty

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Martine Duclos

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: all participants receive the same intervention

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: August 5, 2021
• Study Start: September 7, 2021
• Primary Completion: November 11, 2022
• Study Completion: June 1, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

FR (1)