FrailtyICOPE 29NCT05541731
Implementation Study of the ICOPE Program for the Detection of Frailty in the Elderly Within the Territorial Health Professional Communities (CPTS) of Brest Region
An observational study of Frailty, run by University Hospital, Brest at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Frailty
- How many people
- 56 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jan 2023to 19 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All primary care staff in the two CPTS caring for non-dependent patients aged 70 and over
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read more
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.
- Conditions
- Frailty
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
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, .
Measured: Month 12
Secondary outcomes (2)
Rate of individuals who had one or more of the 6 essential functions for maintaining independence
Calculate the rate of individuals who had one or more of the 6 identified as impaired by the use of the ICOPE program in these two territories.
Number of patients for whom one or more of the 6 functions (mobility, memory, sight, hearing, mental health and nutrition) essential for maintaining autonomy is impaired using the ICOPE MONITOR application. This developed by the Gerontopôle of the Toulouse University Hospital, allows the measurement of the capacities necessary for the prevention of dependency in a few minutes. This application can be downloaded free of charge for health professionals, on a smartphone or tablet.
The assessment of the ICOPE MONITOR application consists of a series of 9 questions, an auditory examination (whisper test) and a chair rise test (have the patient rise from a chair with arms crossed over the chest 5 times in a row as quickly as possible). This assessment identifies whether the patient has any of the 6 impaired functions.
Measured: Month 12
Feeling about the ICOPE MONITOR tool
Perception of the ICOPE MONITOR tool by professionals (qualitative study using semi-structured interviews and group interviews). There are no score.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start19 Jan 2023
- Primary completion5 Jun 2023
- Study completion19 Apr 2024
Why it stopped: Coordinator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541731
- Sponsor's protocol ID
- 29BRC22.0102
- Acronym
- ICOPE 29
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
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.
PubMed 41299329
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Study of the ICOPE Program for the Detection of Frailty in the Elderly Within the Territorial Health Professional Communities (CPTS) of Brest Region
- ClinicalTrials.gov ID
- NCT05541731
- Acronym / sponsor ID
- ICOPE 29 / 29BRC22.0102
- Conditions
- Frailty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Coordinator decision
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All primary care staff in the two CPTS caring for non-dependent patients aged 70 and over
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of identifying frail elderly people aged 70 and over
Time frame: Month 12
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, .
2 secondary outcomes
Rate of individuals who had one or more of the 6 essential functions for maintaining independence
Time frame: Month 12
Feeling about the ICOPE MONITOR tool
Time frame: Month 12
Results and safety
The study was stopped early (reason given: Coordinator decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 41299329Pellen 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Coordinator decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of identifying frail elderly people aged 70 and over (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05541731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.