- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04870086
A Prospective Cohort of Healthcare Workers in France (ESPERES)
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Paris, France, 75013
- Recruiting
- Pitié-Salpêtrière - Charles Foix, AP-HP
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Contact:
- Emmanuelle Liegey, Clinical projects manager
- Phone Number: 01 44 84 17 63
- Email: emmanuelle.liegey@aphp.fr
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Contact:
- Sarra Pochon, Clinical projects manager
- Phone Number: 01 42 16 75 74
- Email: sarra.pochon@aphp.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number and percent of participants who enroll in the ESPERES cohort study by age.
Time Frame: Up to 24 months
|
Up to 24 months
|
Number and percent of participants who enroll in the ESPERES cohort study by health establishment.
Time Frame: Up to 24 months
|
Up to 24 months
|
Number and percent of participants who enroll in the ESPERES cohort study by geographic region
Time Frame: Up to 24 months
|
Up to 24 months
|
Number and percent of participants who enroll in the ESPERES cohort study by profession
Time Frame: Up to 24 months
|
Up to 24 months
|
Proportion of all participants enrolled in the ESPERES cohort study who participate in an ancillary research study
Time Frame: Up to 24 months
|
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
Time Frame: Up to 24 months
|
Up to 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APHP210173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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