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临床试验/NCT07570628
NCT07570628尚未招募不适用

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

CNGE Conseil1 个研究点 分布在 1 个国家目标入组 726 人开始时间: 2027年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
726
试验地点
1
主要终点
Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan

时间窗: 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)

次要结局

  • Rates of all-cause mortality and unplanned hospitalizations among patients included in the study(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(at 3 months after prescription)
  • Acceptability of the use of the Fragiclic platform among healthcare professionals (HCP) who are users and non-users(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)(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)(at the end of patients follow-up, 12 months after enrollment)

研究者

发起方
CNGE Conseil
申办方类型
Other
责任方
Sponsor

研究点 (1)

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