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

11 mei 2026 bijgewerkt door: CNGE Conseil

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:

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

726

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Léon BANH, Dr
Telefoonnummer: 01 60 17 65 65
E-mail: leon.banh@u-pec.fr

Studie Contact Back-up

Naam: Fazia chelli, Mrs
E-mail: f.chelli@cnge.fr

Studie Locaties

Frankrijk
- Rue Charlie-Chaplin
  - Torcy, Rue Charlie-Chaplin, Frankrijk, 77200
    - MSPU Torcy
    - Contact:
      
      Léon Banh
      
      Telefoonnummer: 01 60 17 65 65
      
      E-mail: leon_banh@hotmail.fr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Oudere volwassene

Accepteert gezonde vrijwilligers

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan Tijdsspanne: From patient enrollment to the end of follow-up at 12+/-1 months	This includes the implementation of a screening and/or assessment, whether complete or incomplete (incomplete grid and/or incomplete or not performed PCP)	From patient enrollment to the end of follow-up at 12+/-1 months

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Rates of all-cause mortality and unplanned hospitalizations among patients included in the study Tijdsspanne: From patient enrollment to the end of follow-up at 12+/-1 months	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)	From patient enrollment to the end of follow-up at 12+/-1 months
Number, percentage, and type of personalized care plans prescribed based on the tool used and the degree of PCP implementation Tijdsspanne: at 3 months after prescription	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)	at 3 months after prescription
Acceptability of the use of the Fragiclic platform among healthcare professionals (HCP) who are users and non-users Tijdsspanne: at the end of patients follow-up, 12 months after enrollment	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)	at the end of patients follow-up, 12 months after enrollment
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) Tijdsspanne: at the end of patients follow-up, 12 months after enrollment	Socio-demographic profiles : age, gender, mode of practice Usage profile : number of logins, SEGAm, CGA, and PCP completed, average usage duration	at the end of patients follow-up, 12 months after enrollment
Number and percetange of complete implementation (patients with complete screening or assessment: complete frailty assessment grid and complete PPS) Tijdsspanne: at the end of patients follow-up, 12 months after enrollment	Complete implementation = patients with complete screening or assessment: complete frailty assessment grid and complete PPS	at the end of patients follow-up, 12 months after enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

CNGE Conseil

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

2 januari 2027

Primaire voltooiing (Geschat)

1 april 2028

Studie voltooiing (Geschat)

2 januari 2029

Studieregistratiedata

Eerst ingediend

30 april 2026

Eerst ingediend dat voldeed aan de QC-criteria