- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Léon BANH, Dr
- 전화번호: 01 60 17 65 65
- 이메일: leon.banh@u-pec.fr
연구 연락처 백업
- 이름: Fazia chelli, Mrs
- 이메일: f.chelli@cnge.fr
연구 장소
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Rue Charlie-Chaplin
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Torcy, Rue Charlie-Chaplin, 프랑스, 77200
- MSPU Torcy
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연락하다:
- Léon Banh
- 전화번호: 01 60 17 65 65
- 이메일: leon_banh@hotmail.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rates of all-cause mortality and unplanned hospitalizations among patients included in the study
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025-A00640-49
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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