Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over - Insurance News | InsuranceNewsNet

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September 20, 2019 Newswires
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Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over

NewsRx Women’s Health Daily

2019 SEP 20 (NewsRx) -- By a News Reporter-Staff News Editor at NewsRx Women’s Health Daily -- Staff editors report on the newly launched clinical trial, NCT04085432, which has the following summary description: “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.”

As a matter of record, on September 12, 2019, NewsRx staff editors report that the available information provided by International Longevity Centre France on this trial include:

Tracking Information

Trial Identifier NCT04085432
First Submitted Date September 9, 2019
First Posted Date September 11, 2019
Results First Submitted Date Not Provided
Results First Posted Date Not Provided
Last Update Submitted Date September 9, 2019
Last Update Posted Date September 11, 2019
Primary Completion Date April 30, 2020
Start Date September 30, 2019
Current Primary Outcome Measures •Frailty and pre-frailty diagnosis rate [ Time Frame: October 2019 to April 2020 ] -- Frailty and pre-frailty diagnosis rate are detected by self administered questionnaire and confirmed by the Fried’s frailty phenotype assessment
Current Secondary Outcome Measures •Prevalence of frailty by age and gender [ Time Frame: October 2019 to April 2020 ] -- Prevalence of frailty by age and gender
Other Outcome Measures Not Provided
Change History Complete list of historical revisions of study NCT04085432

Descriptive Information

Brief Title Validation of a Frailty Self Assessment Tool
Official Title Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over
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.
Study Type Observational
Study Phase Not Provided
Study Design Observational Model: Other
Time Perspective: Other
Condition Frailty
Intervention •Other: Self administered questionnaire and Clinical evaluation
Self administered questionnaire and clinical evaluation

Recruitment Information

Recruitment Status Not yet recruiting
Estimated Enrollment 5000
Estimated Completion Date December 31, 2020
Primary Completion Date April 30, 2020 (Final data collection date for primary outcome measure)
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
Sex/Gender Sexes Eligible for Study: All
Ages 70 years and older
Accepts Healthy Volunteers Yes
Contacts Primary contact: Prisca LUCAS, Ph.D, +33674171270, [email protected]
Backup contact: Didier Halimi, MD, +33607555674, [email protected]
Listed Location Countries Not Provided
Removed Location Countries

Administrative Information

NCT Number NCT04085432
Other Study ID Numbers CNAV- ILC France 2
2018-A03324-51
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
Plan to Share Data (IPD) Description Not Provided
Responsible Party International Longevity Centre France
Collaborators Not Provided
Investigators Principal Investigator: Francoise FORETTE, MD, ILC France and Universite Paris Descartes
Information Provided By International Longevity Centre France
Verification Date September 2019

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