NCT04511780

Brief Summary

Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means:

  1. 1.For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs.
  2. 2.For the less severe patients, personals of non-busy units have been transferred in busier ones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
701

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

51 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 12, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

August 12, 2020

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-Traumatic Stress Disorder

    PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)

    3-6 month after the Covid-19 outbreak

Secondary Outcomes (2)

  • anxiety and depression

    3-6 month after the Covid-19 outbreak

  • Burn out

    3-6 month after the Covid-19 outbreak

Study Arms (1)

Caregivers

• Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak

Other: questionnaire filling

Interventions

assessment of post-traumatic stress, anxiety and burn out

Caregivers

Eligibility Criteria

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

Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak

You may qualify if:

  • Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak
  • Approved to participate

You may not qualify if:

  • Participation refusal
  • No internet connection for responding to the questionnaire with REDCAP file

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (51)

Intensive Care Unit, CHU d'Amiens

Amiens, 80054, France

Location

Intensive Care Unit, CHU d'Angers

Angers, 49933, France

Location

CHU de Besançon

Besançon, 25030, France

Location

CHU de Bordeaux, Hôpital Pellegrin

Bordeaux, 33076, France

Location

Intensive care Unit CHU de Brest Hôpital Cavale Blanche

Brest, 29609, France

Location

CHU de Caen

Caen, 14033, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

AP-HP, Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de dijon

Dijon, 21079, France

Location

CHU de Grenoble, Hôpital Michalon

La Tronche, 38700, France

Location

AP_HP, Hôpital du Kremlin Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Intensive Care Unit, CHRU de Lille

Lille, 59037, France

Location

Intensive Care Unit, CHU de Limoges

Limoges, 87042, France

Location

Hôpitaux civils de Lyon, Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Hôpitaux civils de Lyon, Hôpital Louis Pradel

Lyon, 69394, France

Location

Hôpitaux civils de Lyon, Hôpital Edouard Herriot

Lyon, 69437, France

Location

AP-HM, Hôpital Nord

Marseille, 13005, France

Location

AP-HM, Hôpital Timone adultes, Intensive Care Unit

Marseille, 13005, France

Location

AP-HM, Hôpital Timone adultes, Neurotraumatology

Marseille, 13015, France

Location

AP-HM, Hôpital e la Conception

Marseille, 13385, France

Location

CHU de Montpellier, Hôpital Guy de chauliac

Montpellier, 34295, France

Location

CHU de Montpellier, Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Montpellier, Hôpital St Eloi SAR B

Montpellier, 34295, France

Location

CHU De Montpellier, Hôpital St Eloi-DAR B

Montpellier, 34295, France

Location

CHU De Montpellier, Hôpital St Eloi

Montpellier, 34295, France

Location

Intensive Care Unit, CHU de Mulhouse

Mulhouse, 68051, France

Location

Intensive CAre Unit CHRU de Nancy, Hôpital Central

Nancy, 54000, France

Location

Intensive Care Unit, CHU de Nantes, Hôtel Dieu

Nantes, 44093, France

Location

Intensive Care Unit, CHU de Nantes

Nantes, 44093, France

Location

CHU de Nice

Nice, 06000, France

Location

Intensive care Unit CHU Nîmes

Nîmes, 30029, France

Location

AP-HP, Hôpital de la Pitié

Paris, 75013, France

Location

AP-HP, Hôpital Bichât

Paris, 75018, France

Location

AP-HP, Hôpital Lariboisière

Paris, 75475, France

Location

AP6HP, Hôpital St Loui

Paris, 75475, France

Location

AP_HP, Hôpital G Pompidou

Paris, 75908, France

Location

AP-HP, Hôpital St Antoine

Paris, 75970, France

Location

CH de Perpignan

Perpignan, 66046, France

Location

CHU de Bordeaux, Hôpital Haut Leveque

Pessac, 33604, France

Location

Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Intensive care Unit CHU de Rennes

Rennes, 35033, France

Location

CHU de Rouen

Rouen, 76031, France

Location

CHU de St Etienne, Hôpital Nord

Saint-Etienne, 42055, France

Location

Intensive Care Unit, CHU de Nantes, Hôpital Laennec

Saint-Herblain, 44800, France

Location

Intesive Care Unit CHRU de Strasbourg, Hôpital civil

Strasbourg, 67091, France

Location

Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre

Strasbourg, 67098, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Intensive care unit CHU de Tours

Tours, 37044, France

Location

Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

CH de Vesoul

Vesoul, 70014, France

Location

Related Publications (1)

  • Roger C, Ling L, Petrier M, Elotmani L, Atchade E, Allaouchiche B, Aubrun F, Constantin JM, Dahyot-Fizelier C, Delhaye N, Dupont H, Fischer MO, Garnier M, Gayat E, Ichai C, Jaber S, Morel J, Plaud B, Rimmele T, Robin S, Saba R, Joynt GM, Lefrant JY, Fabbro-Peray P, Lipman J, Conejero I, Laupland K. Occurrences of post-traumatic stress disorder, anxiety, depression, and burnout syndrome in ICU staff workers after two-year of the COVID-19 pandemic: the international PSY-CO in ICU study. Ann Gen Psychiatry. 2024 Jan 3;23(1):3. doi: 10.1186/s12991-023-00488-5.

MeSH Terms

Conditions

Critical IllnessCOVID-19Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Jean Yves LEFRANT

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 13, 2020

Study Start

February 25, 2021

Primary Completion

July 20, 2022

Study Completion

July 20, 2022

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations