NCT05163457

Brief Summary

The aging of population lead to study ways to prevent dependence. Frailty is a precursor to dependence which can be reversible. In the literature, estimate of prevalence of frailty is highly variable depending on the frailty definition, the population studied and the screan tool used. In fact, many scales to measure frailty have emerged without gold standard. The SEGAm showed its usefulness in aged patients living at home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

January 6, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

December 6, 2021

Last Update Submit

March 9, 2022

Conditions

Frailty

Keywords

Frailty - SEGAm - living at home

Outcome Measures

Primary Outcomes (1)

  • Frailty

    Frailty evaluated using SEGA modified scale (SEGAm). SEGAm includes 13 items (coded from 0 to 2) to obtain a global score out of 26 points. Patients with a score less than or equal to 8 are considered not fragile. Patients with a score between 8 and 11 are considered fragile. Patients with a score greater than or equal to 11 are considered very fragile.

    Day 0

Study Arms (1)

aged of 75 and more living at home

aged of 75 and more living at home" group: patients aged of 75 and more living at home

Other: Data collection

Interventions

Data collectionOTHER

frailty evaluation

aged of 75 and more living at home

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients aged of 75 and more living at home

You may qualify if:

  • male or female
  • aged of 75 and more
  • living at home
  • agreeing to participate in the study

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison de Santé Pluridisciplinaire de Bar sur Seine

Bar-sur-Seine, Grand Est, 10110, France

Location

MeSH Terms

Conditions

Frailty

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 20, 2021

Study Start

January 6, 2022

Primary Completion

February 22, 2022

Study Completion

February 22, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)