Validation of a Frailty Self Assessment Tool

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085432
• Other study ID #: CNAV- ILC France 2
• Secondary ID: 2018-A03324-51
• Status: Completed
• Start date: October 3, 2019
• Est. completion date: August 19, 2020

Study information

• Verified date: September 2020
• Source: International Longevity Centre France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5134
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Self administered questionnaire and Clinical evaluation
Self administered questionnaire and clinical evaluation

Locations

Country	Name	City	State
France	Broca Hospital Geriatric Department	Paris
France	GERONTOPOLE of the Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
International Longevity Centre France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of frailty by age and gender	Prevalence of frailty by age and gender	October 2019 to August 2020