NCT04844515

Brief Summary

This is the first study performed within the ESPERES cohort, related to prevention against COVID-19, in particular vaccination against COVID-19 and more broadly on the COVID-19 pandemic. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2023

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

April 13, 2021

Last Update Submit

June 17, 2022

Conditions

Keywords

Healthcare workersPreventive measuresAttitudesCOVID-19

Outcome Measures

Primary Outcomes (1)

  • The COVID-19 vaccine intention with the question: "Do you intend to get vaccinated against COVID-19?" : I am already vaccinated / Yes, as soon as possible / Yes, but I prefer to wait before getting vaccinated / No, I don't think I'm gonna get vaccinated

    Up to 24 months

Secondary Outcomes (17)

  • The COVID-19 vaccine intention in HCWs participants according to the characteristics of the vaccines (country of the manufacturer, technology used, number of doses, etc.) and of the HCWs

    Up to 24 months

  • Potential individual sociocognitive factors in the acceptance of COVID-19 vaccination, based on models developed for vaccine hesitation (5C psychological antecedents of vaccination adapted for COVID-19 vaccination and HCWs). (eleven points-Likert scales)

    Up to 24 months

  • The perceptions of participants regarding the strategies for managing the pandemic and the progress of the health crisis and the pandemic (eleven points-Likert scales)

    Up to 24 months

  • The healthy behaviors in other contexts (especially influenza vaccination over the last years)

    Up to 24 months

  • The methods and sources of information concerning questions relating to health: media (website, social networks, television, radio or written press), nature (mainstream, classic or alternative media), etc.

    Up to 24 months

  • +12 more secondary outcomes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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\_COVID-19 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.

You may qualify if:

  • 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)

You may not qualify if:

  • \- No internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié-Salpêtrière - Charles Foix, AP-HP

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

COVID-19Behavior

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Florence Tubach, MD, PHD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Tubach, MD, PHD

CONTACT

Sandra Fournier, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 14, 2021

Study Start

April 9, 2021

Primary Completion

October 1, 2022

Study Completion

April 23, 2023

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations