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临床试验/NCT04870086
NCT04870086招募中不适用

A Prospective Cohort of Healthcare Workers in France

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2021年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15,000
试验地点
1
主要终点
Number and percent of participants who enroll in the ESPERES cohort study by age.

研究概览

简要总结

ESPERES is a national prospective e-cohort study providing a resource for collecting information on healthcare workers (HCWs) currently working in France. The overall goal of ESPERES is to develop the infrastructure necessary to create and engage a community of HCWs who may be eligible for participation in future research studies. ESPERES is set up to answer research questions, in the field of prevention for HCWs, prevention for their own health, that of their relatives, their colleagues, and users of the hospital. These research questions will be carried out in the context of specific subsequent studies. The first study that will be carried out is related to prevention against COVID-19, in particular vaccination against COVID-19 and more broadly on the COVID-19 pandemic.

详细描述

The study population will be made up of HCWs. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.). ESPERES will be offered to all the HCWs of the Assistance Publique - Hôpitaux de Paris (AP-HP) establishments and to other public or private health establishments (lucrative or not) in the Ile-De-France region and to establishments in other French regions, in order to diversify the contexts.

Each participant is self-included and collects his own data via a web interface. This cohort is open, meaning that eligible people can be included until the end of the study (no limited inclusion period). This cohort will start in 2021 and is scheduled for an initial duration of 24 months but may be extended as part of amendments.

Participants will be regularly asked to answer online questionnaires lasting at most 20 minutes. The frequency of these questionnaires will not exceed one questionnaire every 2 weeks (and will generally be more spaced out). During their follow-up in the cohort, participants may be asked, depending on their characteristics, to participate in studies nested in the cohort.

All data from ESPERES will be gathered in a health data repository. The statistical analyses planned in the research protocol and those responding to specific subsequent studies nested in ESPERES and validated by the scientific committee, will be performed by the pharmaco-epidemiology center (CEPHEPI), under the responsibility of Dr Candice ESTELLAT and Pr Florence TUBACH. The CEPHEPI is backed by the public health department of the hospital group Pitié-Salpêtrière - Charles Foix, AP-HP.

A calculation of the sample size is not justified for this study as it aims to answer several research questions in a cohort. However, a number about 15,000 participants in ESPERES are expected.

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
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Legal age
  • Healthcare workers defined as individuals who currently work in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.)
  • Agreeing to participate (digital consent)

排除标准

  • No internet access

结局指标

主要结局

Number and percent of participants who enroll in the ESPERES cohort study by age.

时间窗: Up to 24 months

Number and percent of participants who enroll in the ESPERES cohort study by health establishment.

时间窗: Up to 24 months

Number and percent of participants who enroll in the ESPERES cohort study by geographic region

时间窗: Up to 24 months

Number and percent of participants who enroll in the ESPERES cohort study by profession

时间窗: Up to 24 months

Proportion of all participants enrolled in the ESPERES cohort study who participate in an ancillary research study

时间窗: Up to 24 months

Proportion of participants who continue to supple information about their health to the ESPERES cohort study at various time points after their enrollment

时间窗: Up to 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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