ESPERES: A Prospective Cohort of Healthcare Workers in France

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04870086
Collaborator
(none)
15,000
1
60.6
247.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Type:
    Observational
    Anticipated Enrollment :
    15000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Cohort of Healthcare Workers in France
    Actual Study Start Date :
    Apr 6, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Apr 23, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number and percent of participants who enroll in the ESPERES cohort study by age. [Up to 24 months]

    2. Number and percent of participants who enroll in the ESPERES cohort study by health establishment. [Up to 24 months]

    3. Number and percent of participants who enroll in the ESPERES cohort study by geographic region [Up to 24 months]

    4. Number and percent of participants who enroll in the ESPERES cohort study by profession [Up to 24 months]

    5. Proportion of all participants enrolled in the ESPERES cohort study who participate in an ancillary research study [Up to 24 months]

    6. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pitié-Salpêtrière - Charles Foix, AP-HP Paris France 75013

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Florence Tubach, MD, PHD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04870086
    Other Study ID Numbers:
    • APHP210173
    First Posted:
    May 3, 2021
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris

    Study Results

    No Results Posted as of Jun 21, 2022