Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING) (FRAGING)
Primary Purpose
Frailty
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaire
accelerometer
Sponsored by
About this trial
This is an interventional screening trial for Frailty focused on measuring Elderly, Community-dwelling, Screening, Prevention, Health
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.
Sites / Locations
- CHU de Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
people aged 65 years or more
Arm Description
men or women, age Superior to 65 years
Outcomes
Primary Outcome Measures
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
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),
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),
Evaluation of quality of life
measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions)
Evaluation of caregiver
measured by the caregiver questionnaire (MiniZarit) . (min: 0-max: 7; lower scores referring to good conditions)
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).
Secondary Outcome Measures
Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.
measured in pourcent (%)
Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.
measured in pourcent (%)
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 (%)
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 (%)
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 (%)
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
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)
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)
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)
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)
Full Information
NCT ID
NCT04992286
First Posted
June 28, 2021
Last Updated
January 31, 2023
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
1. Study Identification
Unique Protocol Identification Number
NCT04992286
Brief Title
Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING)
Acronym
FRAGING
Official Title
Detection, Evaluation and Monitoring of Frailties in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Elderly, Community-dwelling, Screening, Prevention, Health
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all participants receive the same intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
people aged 65 years or more
Arm Type
Experimental
Arm Description
men or women, age Superior to 65 years
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Description
questionnaire to evaluate fragility
Intervention Type
Other
Intervention Name(s)
accelerometer
Intervention Description
To evaluate physical activity level
Primary Outcome Measure Information:
Title
Medico-economic relevance of early detection of frailty through a day dedicated to this theme organized in a rural and semi-urban area
Description
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
Time Frame
Baseline
Title
Evaluation of precarity
Description
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),
Time Frame
Baseline
Title
Evaluation of psychological aspect
Description
measured by the psychological aspect measured by the dedicated questionnaire (PHQ-9) (min: 0-max: 27; lower scores referring to good conditions),
Time Frame
Baseline
Title
Evaluation of quality of life
Description
measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions)
Time Frame
Baseline
Title
Evaluation of caregiver
Description
measured by the caregiver questionnaire (MiniZarit) . (min: 0-max: 7; lower scores referring to good conditions)
Time Frame
Baseline
Title
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).
Description
Effectiveness is measured by the quality of life score (LEIPAD) (min: 0-max: 132; lower scores referring to good conditions).
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Prevalence of frailty among people aged 65 or more in the Mauriac and Vichy community health regions.
Description
measured in pourcent (%)
Time Frame
Baseline
Title
Prevalence of vaccination rate among people aged 65 or more in the Mauriac and Vichy community health regions.
Description
measured in pourcent (%)
Time Frame
Baseline
Title
Prevalence of the rate of organized cancer screening among people aged 65 or more in the Mauriac and Vichy community health regions.
Description
measured in pourcent (%)
Time Frame
Baseline
Title
Prevalence of the rate of risky alcohol consumption among people aged 65 or more in the Mauriac and Vichy community health regions.
Description
measured in pourcent (%)
Time Frame
Baseline
Title
Prevalence of participants with a high cardiovascular risk factor among people aged 65 or more in the Mauriac and Vichy community health regions.
Description
measured in pourcent (%)
Time Frame
Baseline
Title
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.
Description
measured by physical examination by physician
Time Frame
Baseline
Title
To measure physical activity levels of 65 years or older in a rural and a semi-urban population
Description
measured by the questionnaire (ONAPS-Q) and by accelerometer (MET.minutes/week)
Time Frame
Baseline
Title
To measure physical inactivity levels of 65 years or older in a rural and a semi-urban population
Description
measured by - sedentary time measured by the questionnaire (ONAPS-Q) and by accelerometer (minutes per day) (no scale)
Time Frame
Baseline
Title
Modeling the flow of screened and identified frail participants who will be managed by type of frailty identified
Description
- Categorization of the health pathways followed by the study cohort (no unit of measure)
Time Frame
Baseline
Title
Modeling the flow of screened and identified frail participants who will be managed by type of frailty identified (monte Carlo microstimulation)
Description
measured by - Monte Carlo micro-simulation that will model the flows of participants (no unit of measure)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Duclos
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING)
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