Validation of a Frailty Self Assessment Tool

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Broca Hospital Geriatric Department, Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self administered questionnaire and Clinical evaluation

Other

Self administered questionnaire and clinical evaluation

Primary outcomes

Frailty and pre-frailty diagnosis rate

Time frame: October 2019 to August 2020

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

Secondary outcomes

Prevalence of frailty by age and gender

Time frame: October 2019 to August 2020

Prevalence of frailty by age and gender

Sponsors and collaborators

Lead sponsor

International Longevity Centre France

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Sep 11, 2019
Registry last updated: Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed