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NCT Number: NCT07570628

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

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

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Key information

Conditions

Frailty At Older Adults Geriatric Assessment Implementation Research Interprofessional Collaboration Primary Care

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

Secondary outcomes

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

  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)

    Time frame: 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

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fazia chelli, Mrs

CONTACT

[email protected]

Léon BANH, Dr

CONTACT

[email protected]

01 60 17 65 65

Sponsors and collaborators

Lead sponsor

CNGE Conseil

Other

Registry information

Official study 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

Acronym: FRAGICLIC

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
May 6, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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