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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. mai 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

726

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Léon BANH, Dr
Telefonnummer: 01 60 17 65 65
E-post: leon.banh@u-pec.fr

Studer Kontakt Backup

Navn: Fazia chelli, Mrs
E-post: f.chelli@cnge.fr

Studiesteder

Frankrike
- Rue Charlie-Chaplin
  - Torcy, Rue Charlie-Chaplin, Frankrike, 77200
    - MSPU Torcy
    - Ta kontakt med:
      
      Léon Banh
      
      Telefonnummer: 01 60 17 65 65
      
      E-post: leon_banh@hotmail.fr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Eldre voksen

Tar imot friske frivillige

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Rates of all-cause mortality and unplanned hospitalizations among patients included in the study Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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) Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CNGE Conseil

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

2. januar 2027

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

2. januar 2029

Datoer for studieregistrering

Først innsendt

30. april 2026

Først innsendt som oppfylte QC-kriteriene