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Validation of a Frailty Self Assessment Tool

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04085432
Enrollment
5134
Registered
2019-09-11
Start date
2019-10-03
Completion date
2020-08-19
Last updated
2020-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

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.

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.

Interventions

OTHERSelf administered questionnaire and Clinical evaluation

Self administered questionnaire and clinical evaluation

Sponsors

International Longevity Centre France
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frailty and pre-frailty diagnosis rateOctober 2019 to August 2020Frailty and pre-frailty diagnosis rate are detected by self administered questionnaire and confirmed by the Fried's frailty phenotype assessment

Secondary

MeasureTime frameDescription
Prevalence of frailty by age and genderOctober 2019 to August 2020Prevalence of frailty by age and gender

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026