Clinical trial NCT05090241: Frailty Prevention in Elders From Reunion Island
Official title: Frailty Prevention in Elders From Reunion Island: Detection of Frailty, Age-related Issues and Risk of Falling Among Community Dwelling Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatric Assessment
Frail Elderly Syndrome
Prevention
Fall Patients
Lead sponsor: Universite de La Reunion
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Institut de Recherche pour le Developpement
name: Centre Hospitalier Universitaire de la Réunion
name: General Social Security Fund
First posted: 2021-10-22
Enrollment: 147
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 65 years of age consulting a general practice. Consecutive participant sampling.

Brief summary: In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty.

The study evaluates tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.

Detailed description: The 5P research program is a 6-years program that started in 2016.

Its objective is to set up tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.

The diversity and transversal nature of the research disciplines in this program make it original. This allows it, through common protocols, to explore the concept of frailty and the care pathway of the elderly through different prisms of complementary observations.

This program is deployed in three stages: proof of principle, proof of concept (called 5P-PILOT) and "the Scaling up" (called 5P-ECHELLE). It combines an evaluation of the acceptability of technological detection tools, a measurement of the impact of prevention workshops on the loss of autonomy among independent frail elderly people and an evaluation of tools to help detect frailty.

The ageing of the population poses a real societal challenge. The loss of autonomy, which is the result of multiple individual or environmental factors for the ageing person, has a costly impact in terms of recourse to care and on the people around them. It is therefore urgent to act on the levers of frailty by acting as early as possible to prevent its irreversibility.

The "5P ECHELLE" project aims to develop a semi-automatic and non-medical method for detecting weak signals of frailty in older people, by combining standardized clinical indicators for assessing their state of robustness with large-scale intelligent detection devices that allow for longitudinal monitoring, while integrating the necessary participatory dimension of the subject.

Eligibility criteria: Inclusion Criteria:

* Persons over 65 years of age
* Retired persons
* Person affiliated to or benefiting from a social security scheme.
* Free and informed consent given

Exclusion Criteria:

* Persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons), pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure
* Difficulty in understanding the French language

Primary outcomes:
measure: Change in the number of falls
timeFrame: Change from baseline in the number of falls to 6 months.
Secondary outcomes:
measure: Change in balance performance
timeFrame: Change from baseline in balance performance to 6 months.
measure: Change in gait performance
timeFrame: Change from baseline in balance and gait performance to 6 months.
measure: Frailty according to "Fried et al" criteria
timeFrame: Assessed at baseline
measure: The Short Physical Performance Battery (SPPB)
timeFrame: Assessed at baseline
measure: Falls Risk for Older People in the Community (FROP-COM)
timeFrame: Assessed at baseline
measure: Who's Integrated care for older people (ICOPE) screening tool
timeFrame: Assessed at baseline
measure: The "Codex" score
timeFrame: Assessed at baseline
measure: Height in meters
timeFrame: Assessed at baseline
measure: Weight in kilograms
timeFrame: Assessed at baseline
measure: The Evaluation of precariousness and health inequalities in the examination centers" (EPICES) score
timeFrame: Assessed at baseline
measure: Standardised Assessment of Personality - Abbreviated Scale (SAPAS) Moran
timeFrame: Assessed at baseline
measure: The frailty of groups with equal resources (FRAGIRE) grid.
timeFrame: Assessed at baseline
measure: Medical Outcomes Study 36-item Short-Form (SF-36)
timeFrame: Assessed at baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Assessed at baseline
measure: Hearing Handicap Inventory for the Elderly Screening (HHIE-S)
timeFrame: Assessed at baseline
measure: Mini Mental State Examination (MMSE)
timeFrame: Assessed at baseline
measure: World Health Organization (WHO) visual acuity measurement
timeFrame: Assessed at baseline
measure: The Mini Nutritional Assessment (MNA)
timeFrame: Assessed at baseline
Other outcomes:
Locations:
city: Saint-Philippe
country: Réunion
facility: MSPU Care Austral
state: La Réunion
city: Saint-Joseph
country: Réunion
facility: Cabinet Dr HUCHOT et Dr GENSOUS
Study officials:
affiliation: Centre Hospitalier Universitaire de La Reunion
name: Jean-Marc EYCHENE, MD
role: STUDY_DIRECTOR
affiliation: Laboratoire Borelli
name: Pierre-Paul VIDAL, MD
role: STUDY_DIRECTOR
affiliation: Institut de Recherche pour le Développement (IRD)
name: Frederic SANDRON
role: STUDY_DIRECTOR
affiliation: Universite de La Reunion
name: Jean-Marc FRANCO, MD
role: STUDY_DIRECTOR
References:
citation: Legrand F, Eychene JM, Audiffren J, Klein A, Labourdette C, Nicolai A, Sandron F, Vidal PP. The 5P program, personalized and participatory primary prevention pathway: Rational and design of a clinical trial in general practice. Contemp Clin Trials Commun. 2021 Jun 3;22:100786. doi: 10.1016/j.conctc.2021.100786. eCollection 2021 Jun.
citation: Legrand F, Eychene JM, Audiffren J, Klein A, Labourdette C, Nicolai A, Sandron F, Vidal PP. Description of Participants in the "Atout Age Mobility" Prevention Workshops at the University Hospital Center of La Reunion: A Prospective Study. J Nutr Health Aging. 2021;25(5):628-636. doi: 10.1007/s12603-021-1604-8.