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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04870086
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Florence Tubach, MD, PHD
Phone 01 42 16 05 88
Email florence.tubach@aphp.fr
Status Recruiting
Phase
Start date April 6, 2021
Completion date April 23, 2026

See also
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