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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 de maio de 2026 atualizado por: 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

726

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Léon BANH, Dr
Número de telefone: 01 60 17 65 65
E-mail: leon.banh@u-pec.fr

Estude backup de contato

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

Locais de estudo

França
- Rue Charlie-Chaplin
  - Torcy, Rue Charlie-Chaplin, França, 77200
    - MSPU Torcy
    - Contato:
      
      Léon Banh
      
      Número de telefone: 01 60 17 65 65
      
      E-mail: leon_banh@hotmail.fr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Rates of all-cause mortality and unplanned hospitalizations among patients included in the study Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

CNGE Conseil

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

2 de janeiro de 2027

Conclusão Primária (Estimado)

1 de abril de 2028

Conclusão do estudo (Estimado)

2 de janeiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

30 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ