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Psychological Impact of COVID-19 Outbreak on Caregivers

NCT ID: NCT04511780

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-09-30

Brief Summary

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

All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms.

In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.

Detailed Description

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Conditions

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Critical Illness Covid19 Stress Disorders, Post-Traumatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

questionnaire filling

Intervention Type OTHER

assessment of post-traumatic stress, anxiety and burn out

Interventions

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questionnaire filling

assessment of post-traumatic stress, anxiety and burn out

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Participation refusal
* No internet connection for responding to the questionnaire with REDCAP file
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Yves LEFRANT

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

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Intensive Care Unit, CHU d'Amiens

Amiens, , France

Site Status

Intensive Care Unit, CHU d'Angers

Angers, , France

Site Status

CHU de Besançon

Besançon, , France

Site Status

CHU de Bordeaux, Hôpital Pellegrin

Bordeaux, , France

Site Status

Intensive care Unit CHU de Brest Hôpital Cavale Blanche

Brest, , France

Site Status

CHU de Caen

Caen, , France

Site Status

CHU de Clermont Ferrand

Clermont-Ferrand, , France

Site Status

AP-HP, Hôpital Henri Mondor

Créteil, , France

Site Status

CHU de dijon

Dijon, , France

Site Status

CHU de Grenoble, Hôpital Michalon

La Tronche, , France

Site Status

AP_HP, Hôpital du Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Intensive Care Unit, CHRU de Lille

Lille, , France

Site Status

Intensive Care Unit, CHU de Limoges

Limoges, , France

Site Status

Hôpitaux civils de Lyon, Hôpital de la Croix Rousse

Lyon, , France

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Hôpitaux civils de Lyon, Hôpital Louis Pradel

Lyon, , France

Site Status

Hôpitaux civils de Lyon, Hôpital Edouard Herriot

Lyon, , France

Site Status

AP-HM, Hôpital Nord

Marseille, , France

Site Status

AP-HM, Hôpital Timone adultes, Intensive Care Unit

Marseille, , France

Site Status

AP-HM, Hôpital Timone adultes, Neurotraumatology

Marseille, , France

Site Status

AP-HM, Hôpital e la Conception

Marseille, , France

Site Status

CHU de Montpellier, Hôpital Guy de chauliac

Montpellier, , France

Site Status

CHU de Montpellier, Hôpital Lapeyronie

Montpellier, , France

Site Status

CHU de Montpellier, Hôpital St Eloi SAR B

Montpellier, , France

Site Status

CHU De Montpellier, Hôpital St Eloi-DAR B

Montpellier, , France

Site Status

CHU De Montpellier, Hôpital St Eloi

Montpellier, , France

Site Status

Intensive Care Unit, CHU de Mulhouse

Mulhouse, , France

Site Status

Intensive CAre Unit CHRU de Nancy, Hôpital Central

Nancy, , France

Site Status

Intensive Care Unit, CHU de Nantes, Hôtel Dieu

Nantes, , France

Site Status

Intensive Care Unit, CHU de Nantes

Nantes, , France

Site Status

CHU de Nice

Nice, , France

Site Status

Intensive care Unit CHU Nîmes

Nîmes, , France

Site Status

AP-HP, Hôpital de la Pitié

Paris, , France

Site Status

AP-HP, Hôpital Bichât

Paris, , France

Site Status

AP-HP, Hôpital Lariboisière

Paris, , France

Site Status

AP6HP, Hôpital St Loui

Paris, , France

Site Status

AP_HP, Hôpital G Pompidou

Paris, , France

Site Status

AP-HP, Hôpital St Antoine

Paris, , France

Site Status

CH de Perpignan

Perpignan, , France

Site Status

CHU de Bordeaux, Hôpital Haut Leveque

Pessac, , France

Site Status

Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud

Pierre-Bénite, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

Intensive care Unit CHU de Rennes

Rennes, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

CHU de St Etienne, Hôpital Nord

Saint-Etienne, , France

Site Status

Intensive Care Unit, CHU de Nantes, Hôpital Laennec

Saint-Herblain, , France

Site Status

Intesive Care Unit CHRU de Strasbourg, Hôpital civil

Strasbourg, , France

Site Status

Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre

Strasbourg, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

Intensive care unit CHU de Tours

Tours, , France

Site Status

Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

CH de Vesoul

Vesoul, , France

Site Status

Countries

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France

Central Contacts

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Jean Yves LEFRANT

Role: CONTACT

Phone: +33466683331

Email: [email protected]

Facility Contacts

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Yazine MAHJOUB

Role: primary

Sigismond LASOCKI

Role: primary

Sébastien PILI-FLOURY

Role: primary

Matthieu BIAIS

Role: primary

Olivier HUET

Role: primary

Mar Olivier FISCHER

Role: primary

Jean Etienne BAZIN

Role: primary

Olivier LANGERON

Role: primary

Belaid BOUHEMAD

Role: primary

Jean François PAYEN

Role: primary

Jacques DURANTEAU

Role: primary

Eric PIKNIS

Role: primary

Nathalie NATHAN-DENIZOT

Role: primary

Frédéric AUBRUN

Role: primary

Jean Luc FELLAHI

Role: primary

Thomas RIMMELE

Role: primary

Marc LEONE

Role: primary

Lionel VELLY

Role: primary

Nicolas BRUDER

Role: primary

Jacques ALBANESE

Role: primary

Pierre François PERRIGAULT

Role: primary

Xavier CAPDEVILA

Role: primary

Géralde CHANQUES

Role: primary

Audrey DE JONG

Role: primary

Samir JABER

Role: primary

Guylaine LABRO

Role: primary

Gérard AUDIBERT

Role: primary

Antoine ROQUILLY

Role: primary

Karim ASEHNOUNE

Role: primary

ICHAI Carole

Role: primary

Jean Yves LEFRANT

Role: primary

Jean Michel CONSTANTIN

Role: primary

Philippe MONTRAVERS

Role: primary

Etienne GAYAT

Role: primary

Benoit PLAUD

Role: primary

Bernard CHOLLEY

Role: primary

marc GARNIER

Role: primary

Olivier BARBOT

Role: primary

Olivier JOANNES BOYAU

Role: primary

Bernard ALLAOUCHICHE

Role: primary

Claire DAHYOT FIZELIER

Role: primary

Philippe SEGUIN

Role: primary

Benoit VEBER

Role: primary

Jérôme MOREL

Role: primary

Karim LAKHAL

Role: primary

Julien POTTECHER

Role: primary

Olivier FOURCADE

Role: primary

Francis REMERAND

Role: primary

Marie reine LOSSER

Role: primary

Bérangère VIVET

Role: primary

Other Identifiers

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Local/2020/JYL-03

Identifier Type: -

Identifier Source: org_study_id