NCT04558437

Brief Summary

The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 10, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 22, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

June 10, 2020

Last Update Submit

September 21, 2020

Conditions

Keywords

prevalencepost-traumatic stress disorder (PTSD),epidemicCOVID19

Outcome Measures

Primary Outcomes (1)

  • Prevalence of PTSD among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months or 6 months).

    Rate of respondents with a PTSD defined as score higher or equal to 32 for PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) at, at least, one of the three measures (inclusion, M3 or M6)

    6 months

Secondary Outcomes (2)

  • Prevalence of Anxiety Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months and 6 months).

    baseline, 3 months and 6 months

  • Prevalence of Depressive Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, M3 and M6).

    baseline, 3 months and 6 months

Interventions

Questionnaire at M0 M3 M6: PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) HAD (Hospital Anxiety and Depression Scale) SDS (Sheehan Disability Scales)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Care teams and supports of AP-HP hospitals

You may qualify if:

  • AP-HP professionals on duty during the COVID epidemic agreeing to participate in the three stages of the study.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Paris, Île-de-France Region, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepressionCOVID-19Combat Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Antoine PELISSOLO, MD-PhD

CONTACT

Pierre WOLKENSTEIN, MD-PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 10, 2020

First Posted

September 22, 2020

Study Start

June 12, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Locations