FRAGICLIC : 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

NCT07570628 | Not Yet Recruiting

• 1 other identifier: 2025-A00640-49
• Study Type: observational
• Target: 726
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Frailty at Older Adults; Primary Care; Geriatric Assessment; Implementation Research; Interprofessional Collaboration

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (5)

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

  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

  at 3 months after prescription

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

  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)

  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)

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CNGE Conseil: lead

Study Sites (1)

MSPU Torcy

Torcy, Rue Charlie-Chaplin, 77200, France

Location

Central Study Contacts

Léon BANH, Dr

CONTACT

01 60 17 65 65; leon.banh@u-pec.fr

Fazia chelli, Mrs

CONTACT

f.chelli@cnge.fr

Study Design

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

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): January 2, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 2, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)