- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07570628
Implementation of a Clinical Decision Support System in Primary Care for the Screening and Assessment of Frailty in Patients Aged 65 and Over (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
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
A tanulmány áttekintése
Állapot
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Léon BANH, Dr
- Telefonszám: 01 60 17 65 65
- E-mail: leon.banh@u-pec.fr
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Fazia chelli, Mrs
- E-mail: f.chelli@cnge.fr
Tanulmányi helyek
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Rue Charlie-Chaplin
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Torcy, Rue Charlie-Chaplin, Franciaország, 77200
- MSPU Torcy
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Kapcsolatba lépni:
- Léon Banh
- Telefonszám: 01 60 17 65 65
- E-mail: leon_banh@hotmail.fr
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Rates of all-cause mortality and unplanned hospitalizations among patients included in the study
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 2025-A00640-49
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