NCT04012840

Brief Summary

As an active and healthy ageing, "Successful Ageing" is a societal challenge for all countries members according to the European Commission. This study is intended to contribute to increase healthy, active and non-dependent lifetime. To this end the main goal is to highlight clinical and biological frailty determinants in elderly with potential weaknesses.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress63%
Jun 2018Dec 2030

Study Start

First participant enrolled

June 26, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2030

Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

12 years

First QC Date

July 2, 2019

Last Update Submit

April 11, 2025

Conditions

Keywords

FrailtyFried's criteriaRockwood's criteriaLoss of autonomy,elderly

Outcome Measures

Primary Outcomes (1)

  • Loss of 1 or more point in activities of daily living (ADL) score which assert a loss of autonomy - Loss of 1 or more point in instrumental activities of daily living (IADL) score which assert a loss of autonomy During the monitoring, those evaluatio

    3 years

Secondary Outcomes (4)

  • Assessment of ccurrence of cognitive disorders according Mini Mental State Examination (MMSE)

    3 years

  • Occurrence of drivers of risk of falls : search for orthostatic hypotension (occurrence or missing), leg stance, tandem station, SPPB, TUG, grip force.

    3 years

  • Constated malnourishment according Mini Nutritional Assessment MNA short form

    3 years

  • Occurrence of a depression according Mini Geriatric Depression Scale "mini GDS" ≥ 1

    3 years

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

: +70 years old elderly with a potential frailty whose accept to participate to a geriatric assessment in a prevention center or in a day hospital and to be followed bwith phone calls every 6 months for 3 years.

You may qualify if:

  • Age ≥ 70 years old
  • Patient with frailty risks according to a survey recommended by HAS (Gérontopôle of Toulouse)
  • ADL≥5
  • Agreeing to take part in a geriatric assessment in a prevention center or in a Day hospital in Île-de-France
  • Agreeing to be followed by phone every 6 months for 3 years
  • Eligible to a social security system

You may not qualify if:

  • A stated loss of autonomy
  • Individual under guardianship, curatorship, judicial supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Department

Paris, Île-de-France Region, 75000, France

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Hanon, MD PhD

    Geriatrci Department, Broca Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 9, 2019

Study Start

June 26, 2018

Primary Completion (Estimated)

June 25, 2030

Study Completion (Estimated)

December 25, 2030

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations