NCT05090241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

September 20, 2021

Last Update Submit

May 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the number of falls

    Collection of falls by diary with monthly telephone survey for 6 months. A fall is defined as an event in which an individual inadvertently falls to the ground or any other surface below the level of origin.

    Change from baseline in the number of falls to 6 months.

Secondary Outcomes (18)

  • Change in balance performance

    Change from baseline in balance performance to 6 months.

  • Change in gait performance

    Change from baseline in balance and gait performance to 6 months.

  • Frailty according to "Fried et al" criteria

    Assessed at baseline

  • The Short Physical Performance Battery (SPPB)

    Assessed at baseline

  • Falls Risk for Older People in the Community (FROP-COM)

    Assessed at baseline

  • +13 more secondary outcomes

Interventions

The balance measurement was performed on a force platform. The walk test was carried out using sensors to analyze and retrieve data from the participant's walk (gait speed, step length, duration of the double support phase).

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over 65 years of age consulting a general practice. Consecutive participant sampling.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MSPU Care Austral

Saint-Philippe, La Réunion, 97417, Reunion

Location

Cabinet Dr HUCHOT et Dr GENSOUS

Saint-Joseph, 97480, Reunion

Location

Related Publications (2)

  • 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.

    PMID: 34159279BACKGROUND
  • 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.

    PMID: 33949630BACKGROUND

MeSH Terms

Interventions

Gait

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jean-Marc EYCHENE, MD

    Centre Hospitalier Universitaire de La Reunion

    STUDY DIRECTOR
  • Pierre-Paul VIDAL, MD

    Laboratoire Borelli

    STUDY DIRECTOR
  • Frederic SANDRON

    Institut de Recherche pour le Développement (IRD)

    STUDY DIRECTOR
  • Jean-Marc FRANCO, MD

    Universite de La Reunion

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 22, 2021

Study Start

November 1, 2021

Primary Completion

December 27, 2023

Study Completion

December 27, 2023

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations