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 mayo de 2026 actualizado 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
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
De observación
Inscripción (Estimado)
726
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Léon BANH, Dr
- Número de teléfono: 01 60 17 65 65
- Correo electrónico: leon.banh@u-pec.fr
Copia de seguridad de contactos de estudio
- Nombre: Fazia chelli, Mrs
- Correo electrónico: f.chelli@cnge.fr
Ubicaciones de estudio
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Rue Charlie-Chaplin
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Torcy, Rue Charlie-Chaplin, Francia, 77200
- MSPU Torcy
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Contacto:
- Léon Banh
- Número de teléfono: 01 60 17 65 65
- Correo electrónico: leon_banh@hotmail.fr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Patients aged 65 years older among GP's patients in primary care
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan
Periodo de tiempo: From patient enrollment to the end of follow-up at 12+/-1 months
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This includes the implementation of a screening and/or assessment, whether complete or incomplete (incomplete grid and/or incomplete or not performed PCP)
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From patient enrollment to the end of follow-up at 12+/-1 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rates of all-cause mortality and unplanned hospitalizations among patients included in the study
Periodo de tiempo: From patient enrollment to the end of follow-up at 12+/-1 months
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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)
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From patient enrollment to the end of follow-up at 12+/-1 months
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Number, percentage, and type of personalized care plans prescribed based on the tool used and the degree of PCP implementation
Periodo de tiempo: at 3 months after prescription
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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)
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at 3 months after prescription
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Acceptability of the use of the Fragiclic platform among healthcare professionals (HCP) who are users and non-users
Periodo de tiempo: at the end of patients follow-up, 12 months after enrollment
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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)
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at the end of patients follow-up, 12 months after enrollment
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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)
Periodo de tiempo: at the end of patients follow-up, 12 months after enrollment
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Socio-demographic profiles : age, gender, mode of practice Usage profile : number of logins, SEGAm, CGA, and PCP completed, average usage duration
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at the end of patients follow-up, 12 months after enrollment
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Number and percetange of complete implementation (patients with complete screening or assessment: complete frailty assessment grid and complete PPS)
Periodo de tiempo: at the end of patients follow-up, 12 months after enrollment
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Complete implementation = patients with complete screening or assessment: complete frailty assessment grid and complete PPS
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at the end of patients follow-up, 12 months after enrollment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
2 de enero de 2027
Finalización primaria (Estimado)
1 de abril de 2028
Finalización del estudio (Estimado)
2 de enero de 2029
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2025-A00640-49
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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