Validation of a Frailty Self Assessment Tool

Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over

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.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Other: Self administered questionnaire and Clinical evaluation

Detailed Description

Five thousands (5000) retirees aged 70 and over will be randomly selected from National Retirement Pension Institute (CNAV) retirees (2500 living in Paris and 2500 living in Toulouse). They will receive a letter from the CNAV explaining the study approach and a separate self-assessment frailty questionnaire to be filled in by the retirees at home and sent back in a pre-paid envelope to International Longevity Centre France (ILC-France).

Retirees who have accepted the home assessment are examined by a healthcare professional, blinded to the results of self-administered questionnaire, using the Fried's frailty criteria in order to confirm or infirm the diagnosis of frailty.

The General practitioner will be informed of the investigation results in order to set up a personalized prevention plan.

ILC-France will anonymize both the self-administered questionnaires and the Fried assessments and send them to the Mixed Research Unit (UMR) 1027 in Toulouse.

Comparison of the Fried assessment results with those of the self-questionnaire will confirm the metrological characteristics (false negative, false positive, sensitivity, specificity, predictive value) of the questionnaire.

Secondary analyses will be conducted to compare the prevalence of frailty by age and gender.

The statistical analysis is carried out by the UMR 1027 of Toulouse.

• Study Type: Observational
• Enrollment (Actual): 5134

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Broca Hospital Geriatric Department
  • Toulouse, France, 31300
    • GERONTOPOLE of the Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Retirees aged 70 and over, living at home

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of frailty by age and gender	Prevalence of frailty by age and gender	October 2019 to August 2020

Collaborators and Investigators

• Sponsor: International Longevity Centre France
• Investigators: Principal Investigator: Françoise FORETTE, MD, ILC France and Universite Paris Descartes

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2019
• Primary Completion (Actual): August 19, 2020
• Study Completion (Actual): August 19, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: CNAV- ILC France 2; 2018-A03324-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No