NCT05033223

Brief Summary

The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO. In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products. This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic. It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD. These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

September 1, 2021

Last Update Submit

January 26, 2022

Conditions

Keywords

post traumatic stress disorderPTSDemergency servicesCOVID-19burn-out

Outcome Measures

Primary Outcomes (1)

  • Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale

    : Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening. The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life

    12 months after the end of the second Lockdown (December 2020)

Secondary Outcomes (12)

  • Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale

    9months after the end of the second Lockdown (December 2020)

  • Anxiety evaluation at 12 months using HAD scale

    12months after the end of the second Lockdown (December 2020)

  • Anxiety evaluation at 9 months using HAD scale

    9months after the end of the second Lockdown (December 2020)

  • Depression evaluation at 12 months using HAD scale

    12months after the end of the second Lockdown (December 2020)

  • Depression evaluation at 9 months using HAD scale

    9months after the end of the second Lockdown (December 2020)

  • +7 more secondary outcomes

Study Arms (1)

Follow-up

OTHER
Other: PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults
  • Administrative and technical medical staff of the Hospices Civils de Lyon
  • Contractual or holder
  • Having participated in the COVER PRO study
  • Working in one of the HCL phase 3 departments of the COVID-19 pandemic.
  • Affiliated with a social security system
  • Having signed an informed consent

You may not qualify if:

  • Refusal to participate
  • Major under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Accueil des Urgences

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCOVID-19Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psycho-traumatic consequences of the COVID-19 health crisis among professionals in emergency services and SAMU: multicenter cohort study (COVid in EmeRgency PROfessionnals Long Term)

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 2, 2021

Study Start

October 12, 2021

Primary Completion

January 16, 2022

Study Completion

January 16, 2022

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations