A Prospective Cohort of Healthcare Workers in France

Healthcare Workers Clinical Trial

— ESPERES  

Official title:

A Prospective Cohort of Healthcare Workers in France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870086
• Other study ID #: APHP210173
• Status: Recruiting
• Start date: April 6, 2021
• Est. completion date: April 23, 2026

Study information

• Verified date: June 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Florence Tubach, MD, PHD
• Phone: 01 42 16 05 88
• Email: florence.tubach[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: April 23, 2026
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• No internet access

Related Conditions & MeSH terms

• Healthcare Workers

Locations

Country	Name	City	State
France	Pitié-Salpêtrière - Charles Foix, AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percent of participants who enroll in the ESPERES cohort study by age.		Up to 24 months
Primary	Number and percent of participants who enroll in the ESPERES cohort study by health establishment.		Up to 24 months
Primary	Number and percent of participants who enroll in the ESPERES cohort study by geographic region		Up to 24 months
Primary	Number and percent of participants who enroll in the ESPERES cohort study by profession		Up to 24 months
Primary	Proportion of all participants enrolled in the ESPERES cohort study who participate in an ancillary research study		Up to 24 months
Primary	Proportion of participants who continue to supple information about their health to the ESPERES cohort study at various time points after their enrollment		Up to 24 months