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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02852200
Other study ID # PO12146
Secondary ID
Status Terminated
Phase N/A
First received June 17, 2016
Last updated October 16, 2017
Start date June 2012
Est. completion date March 2013

Study information

Verified date October 2017
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

"Many tools to evaluate frailty have been developed. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home.

It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument. "


Description:

Many tools to evaluate frailty have been developed. However, most are designed for use in the hospital setting, with the resultant drawback that they are not suitable for routine use in the community setting. A few tools have been developed for use in community-dwelling subjects, such as the Cardiovascular Health Study (CHS) developed by Fried from a cohort of subjects aged 65 and older; the Study of Osteoporotic Fractures (SOF); or the SHARE frailty instrument, developed in a cohort of the same name comprising subjects aged 50 years and older living at home. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home. It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument.


Recruitment information / eligibility

Status Terminated
Enrollment 167
Est. completion date March 2013
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Age: 65 years or more

- Living at home

- Able to read and understand French

- With a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SEGAm


Locations

Country Name City State
France Chu de Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Oubaya N, Mahmoudi R, Jolly D, Zulfiqar AA, Quignard E, Cunin C, Nazeyrollas P, Novella JL, Dramé M. Screening for frailty in elderly subjects living at home: validation of the Modified Short Emergency Geriatric Assessment (SEGAm) instrument. J Nutr Health Aging. 2014;18(8):757-64. doi: 10.1007/s12603-014-0466-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The psychometric properties of SEGAm measured by questionnaire The SEGAm to be validated comprises Sheet A, which evaluates frailty per se on a 13-item scale, with each item graded either 0 (most favourable state), 1, or 2 (least favourable state), thus making it possible to classify subjects into three groups: not very frail (score =8), frail (8 12 months after inclusion
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