Prevalence of Frailty Among People Aged 75 and Over Livin... | NCT05163457

Studies
Prevalence of Frailty Among People Aged 75 and Over Living at Home

NCT05163457

Sponsor

Université de Reims Champagne-Ardenne

Status

Completed

Last Update Posted

Mar 10, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Frailty

Interventions

Data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 6, 2022Actual

Primary Completion Date

Feb 22, 2022Actual

Completion Date

Feb 22, 2022Actual

First Submitted Date

Dec 6, 2021

First Submission Date that Met QC Criteria

Dec 6, 2021

First Posted Date

Dec 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2022

Last Update Posted Date

Mar 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The aim of the study is to describe prevalence of frailty in patients aged of 75 and more living at home.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	frailty evaluation	aged of 75 and more living at home

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

patients aged of 75 and more living at home

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maison de Santé Pluridisciplinaire de Bar sur Seine		Bar-sur-Seine	Grand Est	10110	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided