NCT04085432

Brief Summary

The number of elderly is increasing throughout of the world. Aging is associated with increasing diseases that may be preventable. Over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. Frailty can be reversed through appropriate interventions particularly when they are implemented early. Therefore, early detection of frailty is a major objective. The goal of this study is to identify elderly subjects aged 70 years and over at the early stage of frailty by using a self administered questionnaire sent to the participant by mail. The results of the self assessment will be compared to the Fried criteria collected by a clinical examination conducted by a healthcare Professional blinded to the self assessment results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,134

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 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 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

October 3, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

September 9, 2019

Last Update Submit

September 16, 2020

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

  • Frailty and pre-frailty diagnosis rate

    Frailty and pre-frailty diagnosis rate are detected by self administered questionnaire and confirmed by the Fried's frailty phenotype assessment

    October 2019 to August 2020

Secondary Outcomes (1)

  • Prevalence of frailty by age and gender

    October 2019 to August 2020

Interventions

Self administered questionnaire and Clinical evaluationOTHER

Self administered questionnaire and clinical evaluation

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Retirees aged 70 and over, living at home

You may qualify if:

  • Retirees from the National Old-Age Insurance Fund
  • Aged 70 or older,
  • Living at home
  • Representatives of the general population

You may not qualify if:

  • Institutionalized retirees
  • Retirees receiving the Personalised Allowance for Autonomy
  • Retirees who enrolled in previous studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Broca Hospital Geriatric Department

Paris, 75013, France

Location

GERONTOPOLE of the Toulouse University Hospital

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Françoise FORETTE, MD

    ILC France and Universite Paris Descartes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

October 3, 2019

Primary Completion

August 19, 2020

Study Completion

August 19, 2020

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

FR(2)