NCT05541731

Brief Summary

Frailty is a geriatric syndrome resulting from a decrease in physiological reserve capacities altering the mechanisms of adaptation to stress with, in the absence of diagnosis and management, a short-term risk of falls, hospitalization, loss of autonomy and death. In 2019, the World Health Organization has taken up this subject with the objective of reducing the number of dependent people in the world by 15 million, i.e. 150,000 in France. For this purpose, recommendations for integrated care for seniors (Integrated Care for Older People = ICOPE) have been published. 6 functions are essential to maintain autonomy: mobility, memory, sight, hearing, mental health and nutrition. The first step of the ICOPE program consists of screening for a decline in one of these functions using a tool made up of questions or tests that can be carried out in 8 to 10 minutes in primary care by trained non-professionals. The second step is a thorough evaluation of the person screened, leading to the creation of a personalized care plan. In the current state of affairs, despite its recommendations, this identification is not carried out in Brittany. The objective of this study is to demonstrate the feasibility of implementing the first stage of the ICOPE program by seizing the opportunity of the creation in the Brest region of two Territorial Health Professional Communities (CPTS) : Brest Santé Océane and Iroise santé.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
terminated

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

September 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 19, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

September 13, 2022

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of identifying frail elderly people aged 70 and over

    Number of patients screened using the ICOPE (Integrated Care for Older People) program by the primary care professionals of the CPTS Brest Santé Océane and Iroise santé, one in an urban environment and the other in a semi-rural environment. To demonstrate the feasibility of identifying frail elderly people aged 70 and over, using the ICOPE program, by health professionals working in two CPTSs, Brest Santé Océane and Iroise santé, .

    Month 12

Secondary Outcomes (2)

  • Rate of individuals who had one or more of the 6 essential functions for maintaining independence

    Month 12

  • Feeling about the ICOPE MONITOR tool

    Month 12

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All primary care staff in the two CPTS caring for non-dependent patients aged 70 and over

You may qualify if:

  • Primary care staff belonging to one of the 2 CPTS (CPTS Brest Santé Océane and CPTS Iroise santé) and having accepted to participate in the study

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cpts Brest Sante Oceane

Guipavas, France

Location

Cpts Pays D'Iroise

Saint-Renan, France

Location

Related Publications (1)

  • Pellen N, Beurton-Couraud L, Goff-Coquet AL, Tramecon A, Gentric A, Le Reste JY. Five reasons for the failure of frailty screening in primary care: lessons from the experience with ICOPE monitor step 1. BMC Geriatr. 2025 Nov 26;25(1):1059. doi: 10.1186/s12877-025-06789-6.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 15, 2022

Study Start

January 19, 2023

Primary Completion

June 5, 2023

Study Completion

April 19, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending five years following the last visit of the last patient.
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations