Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain (CovIdeDocS)

November 23, 2022 updated by: Direction Centrale du Service de Santé des Armées

The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers.

The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brétigny-sur-Orge, France, 91223
        • Institut de Recherche Biomédicale des Armées
      • Paris, France, 75005
        • Ecole du Val-de-Grâce

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of caregivers from the French Armed Forces Health Service (Medical doctor, nurse, assistant nurse, ...) who have been in employment when the COVID-19 health crisis began in France.

Description

Inclusion Criteria:

  • To be caregivers
  • Have been in employment between March 15 and May 15, 2020

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospital service change
This group is composed of caregivers who changed hospital service during COVID-19 health crisis.
Other: Online questionnaire
Participants will have to complete 3 online self-questionnaires: the first one at enrollment, the second one 1 month after enrollment (M1) and the third one 3 months after enrollment (M3). Each questionnaire will take an estimated 20 minutes to complete.
No hospital service change
This group is composed of caregivers who have not changed hospital service during COVID-19 health crisis.
Other: Online questionnaire
Participants will have to complete 3 online self-questionnaires: the first one at enrollment, the second one 1 month after enrollment (M1) and the third one 3 months after enrollment (M3). Each questionnaire will take an estimated 20 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burn-out Assessment tool (BAT) score at enrollment.
Time Frame: At enrollment
Burn-out Assessment tool (BAT) score at enrollment will be compared between the "hospital service change" group and the "no hospital service change" group.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 13, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-COVID19-33
  • 2020-A02932-37 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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