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Frailty at Older AdultsFRAGICLICNCT07570628

Implementation of a Clinical Decision Support System in Primary Care for the Screening and Assessment of Frailty in Patients Aged 65 and Over

An observational study of Frailty at Older Adults and Primary Care, run by CNGE Conseil at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This observational study aims to evaluate the real-life use of a digital tool (Fragiclic) by general practitioners (GPs) and nurses to screen and assess frailty in adults aged 65 and over. Frailty is a syndrome that increases the risk of loss of autonomy, falls, hospitalizations, or death. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
How many people
726 participants
Where
1 siteFrance
Study dates
2 Jan 2027to 2 Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Patients aged 65 years older among GP's patients in primary care

Who may be able to join

  • Patients aged 65 years or older
  • Patient or trusted person who provided oral non-opposition after receiving full information about the protocol
  • Managed by the general practitioner if the patient or nurse during the study period. If patients are assessed by a nurse : Patients whose general practitioner is a participating physician in the study

Who cannot join

  • Patients unable to express non-opposition or without a trusted person available to express non-opposition
  • Patients whose general practitioner (GP) is not a participating GP in the study
  • Patients or trusted persons who do not speak French

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Léon BANH, Dr contact

01 60 17 65 65

leon.banh@u-pec.fr

Fazia chelli, Mrs contact

f.chelli@cnge.fr

France1 site

  • MSPU Torcy

    Torcy, Rue Charlie-Chaplin, 77200

    Léon Banh, 01 60 17 65 65, leon_banh@hotmail.fr

Other trials in France

About this study

Official title: Implementation of a Clinical Decision Support System in Primary Care for the Screening and Assessment of Frailty in Patients Aged 65 and Over: A Real-World Prospective Cohort Study

This observational study aims to evaluate the real-life use of a digital tool (Fragiclic) by general practitioners (GPs) and nurses to screen and assess frailty in adults aged 65 and over. Frailty is a syndrome that increases the risk of loss of autonomy, falls, hospitalizations, or death. The tool includes simple screening questionnaires (such as SEGAm) and a comprehensive assessment (CGA - Comprehensive Geriatric Assessment) to better manage patients' health.

The main question it aims to answer is:

Read more
  • What proportion of patients aged 65 and over will benefit from frailty screening or assessment using Fragiclic over 12 months?

A secondary question is

  • Does the use of Fragiclic reduce the risk of unplanned hospitalizations or death in these patients?

For the secondary question, researchers will compare patients who received screening or assessment (with or without a Personalized Care Plan (PCP)) to those who did not, to determine if Fragiclic improves their health outcomes.

Participants will not have additional tasks: Their GP or nurse will use Fragiclic during routine consultations. Some patients may be asked to provide information about their health or quality of life (via their healthcare provider).

All data will be collected anonymously and securely

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan

    This includes the implementation of a screening and/or assessment, whether complete or incomplete (incomplete grid and/or incomplete or not performed PCP)

    Measured: From patient enrollment to the end of follow-up at 12+/-1 months

Secondary outcomes (5)

  1. Rates of all-cause mortality and unplanned hospitalizations among patients included in the study

    The rates of all-cause mortality and unplanned hospitalizations among patients included in the study, based on whether they underwent screening or assessment (complete or incomplete implementation) versus no implementation, and according to the assessment tool used within the Fragiclic site (SEGAm alone +/- PCP vs. CGA alone +/- PCP vs. SEGAm+CGA +/- PCP)

    Measured: From patient enrollment to the end of follow-up at 12+/-1 months

  2. Number, percentage, and type of personalized care plans prescribed based on the tool used and the degree of PCP implementation

    Number, percentage, and type of personalized care plans (PPS) prescribed based on the tool used (SEGAm alone vs. EGS alone vs. SEGAm + EGS), and the degree of PPS implementation (actions implemented)

    Measured: at 3 months after prescription

  3. Acceptability of the use of the Fragiclic platform among healthcare professionals (HCP) who are users and non-users

    Feasibility (number of SEGAm, EGS, and PPS completed by users, completion time, patient refusals, number of users, and monthly logins) Perceived satisfaction with the use of the tool (qualitative study) Perceived usefulness of the tool (actions implemented, observed health outcomes) (qualitative study) Perceived difficulties in screening, frailty assessment, and implementing care and support actions (qualitative study)

    Measured: at the end of patients follow-up, 12 months after enrollment

  4. Socio-demographic profiles of healthcare professionals (HCP) who are users and non-users (age, gender, mode of practice) and usage profiles (number of logins, SEGAm, EGS, and PPS completed, average usage duration)

    Socio-demographic profiles : age, gender, mode of practice Usage profile : number of logins, SEGAm, CGA, and PCP completed, average usage duration

    Measured: at the end of patients follow-up, 12 months after enrollment

  5. Number and percetange of complete implementation (patients with complete screening or assessment: complete frailty assessment grid and complete PPS)

    Complete implementation = patients with complete screening or assessment: complete frailty assessment grid and complete PPS

    Measured: at the end of patients follow-up, 12 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start2 Jan 2027 (estimated)
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion2 Jan 2029 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
726 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07570628
Sponsor's protocol ID
2025-A00640-49
Acronym
FRAGICLIC
Status last verified
Apr 2026
First submitted
30 Apr 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty at Older Adults and Primary Care, run by CNGE Conseil at 1 site 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Léon BANH, Dr (01 60 17 65 65, leon.banh@u-pec.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan (time frame: From patient enrollment to the end of follow-up at 12+/-1 months). 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 NCT07570628.

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 13 May 2026.

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