NCT02852200

Brief 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. "

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

June 17, 2016

Last Update Submit

October 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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\<score ≤11), and very frail (score\> 11). The SEGAm was administered by social workers, ergotherapists, nurses and non-medical personnel trained in administration of the instrument.

    12 months after inclusion

Study Arms (1)

SEGAm

Elderly community-dwelling people

Other: SEGAm

Interventions

SEGAmOTHER
SEGAm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly community-dwelling people aged 65 years or over

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

Related Publications (1)

  • Oubaya N, Mahmoudi R, Jolly D, Zulfiqar AA, Quignard E, Cunin C, Nazeyrollas P, Novella JL, Drame 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/s12603-014-0541-1.

    PMID: 25286456BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

August 2, 2016

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

March 1, 2013

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations