Clinical trial NCT04511780: Psychological Impact of COVID-19 Outbreak on Caregivers
Official title: Psychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Covid19
Stress Disorders, Post-Traumatic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-Traumatic Stress Disorder
timeFrame: 3-6 month after the Covid-19 outbreak
Secondary outcomes:
measure: anxiety and depression
timeFrame: 3-6 month after the Covid-19 outbreak
measure: Burn out
timeFrame: 3-6 month after the Covid-19 outbreak
Other outcomes:
Locations:
city: Amiens
country: France
facility: Intensive Care Unit, CHU d'Amiens
city: Angers
country: France
facility: Intensive Care Unit, CHU d'Angers
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hôpital Pellegrin
city: Brest
country: France
facility: Intensive care Unit CHU de Brest Hôpital Cavale Blanche
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Créteil
country: France
facility: AP-HP, Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU de dijon
city: La Tronche
country: France
facility: CHU de Grenoble, Hôpital Michalon
city: Le Kremlin-Bicêtre
country: France
facility: AP_HP, Hôpital du Kremlin Bicêtre
city: Lille
country: France
facility: Intensive Care Unit, CHRU de Lille
city: Limoges
country: France
facility: Intensive Care Unit, CHU de Limoges
city: Lyon
country: France
facility: Hôpitaux civils de Lyon, Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hôpitaux civils de Lyon, Hôpital Louis Pradel
city: Lyon
country: France
facility: Hôpitaux civils de Lyon, Hôpital Edouard Herriot
city: Marseille
country: France
facility: AP-HM, Hôpital Nord
city: Marseille
country: France
facility: AP-HM, Hôpital Timone adultes, Intensive Care Unit
city: Marseille
country: France
facility: AP-HM, Hôpital Timone adultes, Neurotraumatology
city: Marseille
country: France
facility: AP-HM, Hôpital e la Conception
city: Montpellier
country: France
facility: CHU de Montpellier, Hôpital Guy de chauliac
city: Montpellier
country: France
facility: CHU de Montpellier, Hôpital Lapeyronie
city: Montpellier
country: France
facility: CHU de Montpellier, Hôpital St Eloi SAR B
city: Montpellier
country: France
facility: CHU De Montpellier, Hôpital St Eloi-DAR B
city: Montpellier
country: France
facility: CHU De Montpellier, Hôpital St Eloi
city: Mulhouse
country: France
facility: Intensive Care Unit, CHU de Mulhouse
city: Nancy
country: France
facility: Intensive CAre Unit CHRU de Nancy, Hôpital Central
city: Nantes
country: France
facility: Intensive Care Unit, CHU de Nantes, Hôtel Dieu
city: Nantes
country: France
facility: Intensive Care Unit, CHU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Nîmes
country: France
facility: Intensive care Unit CHU Nîmes
city: Paris
country: France
facility: AP-HP, Hôpital de la Pitié
city: Paris
country: France
facility: AP-HP, Hôpital Bichât
city: Paris
country: France
facility: AP-HP, Hôpital Lariboisière
city: Paris
country: France
facility: AP6HP, Hôpital St Loui
city: Paris
country: France
facility: AP_HP, Hôpital G Pompidou
city: Paris
country: France
facility: AP-HP, Hôpital St Antoine
city: Perpignan
country: France
facility: CH de Perpignan
city: Pessac
country: France
facility: CHU de Bordeaux, Hôpital Haut Leveque
city: Pierre-Bénite
country: France
facility: Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: Intensive care Unit CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Herblain
country: France
facility: Intensive Care Unit, CHU de Nantes, Hôpital Laennec
city: Saint-Étienne
country: France
facility: CHU de St Etienne, Hôpital Nord
city: Strasbourg
country: France
facility: Intesive Care Unit CHRU de Strasbourg, Hôpital civil
city: Strasbourg
country: France
facility: Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: Intensive care unit CHU de Tours
city: Vandœuvre-lès-Nancy
country: France
facility: Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois
city: Vesoul
country: France
facility: CH de Vesoul
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Jean Yves LEFRANT
role: PRINCIPAL_INVESTIGATOR
References: