Hospital Cohort Survey of Public Health Post-attack of July 14, 2016 (ECHOS)

January 25, 2024 updated by: Centre Hospitalier Universitaire de Nice

The terrorist attack on the ram truck, which occurred on 14 July 2016 on the Promenade des Anglais in Nice, involved a significant number of casualties in the civilian population: 86 dead including 10 children and adolescents, and 434 wounded. The attack harmed families gathered for a festive event, the national holiday fireworks, and affected both adults and children of all ages. The people directly involved in the attack number in the thousands: wounded, threatened with death, bereaved, direct witnesses, workers - including firefighters and health personnel (in situations of prolonged extreme tension or insecurity).

Following the attacks in Ile-de-France in January and November 2015, Public Health France conducted in 2015 and 2016 two large-scale studies to estimate the psycho-traumatic impact for those involved in the attack, to know the use of care devices to provide useful information, and ultimately provide information to improve the management devices in place. IMPACTS carried out following the attacks of January, ESPA 13 November carried out following the attacks of 13 November 2015, relate to two main types of population:

  • Non-responders (civilian population) present on or near scenes of crime or their relatives.
  • Persons intervened to secure the premises or provide assistance, or provide psychological support the same day or within 3 weeks.

IMPACTS was conducted face-to-face with investigators and concerned 232 participants, 45 people of the medico-psychological relief (Samu, Cump, Hôtel Dieu) between 6 and 10 months after the events. A second wave of interviews took place from 16 to 20 months after the events.

ESPA 13th November took place via a web-based questionnaire and 800 participants took part, including 67 CUMPs, 121 hospital staff and 26 people from Samu between 9 and 12 months after the events.

Based on the expertise of Public Health France and the model developed for the ESPA study on November 13th, the Public Health Department of the University Hospital of Nice wished to carry out a specific study among the health professionals of the University Hospital of Nice and the Hospitals pediatrics of Nice CHU-Lenval, as well as students of the Faculty of Medicine of Nice Sophia-Antipolis.

Many professionals of all categories were directly impacted: either at the scene of the attack as a civilian population or as professionals, or in the care services that received the victims and families (including services of the Pasteur2 hospital, Lenval Hospital on the Promenade des Anglais).

The population of medical students is also included in the study, and external students in particular have made a significant contribution to the Institut Médico-Légal.

This involvement could be done directly (presence as hospital staff at the scene of the attack, care of the victims or their relatives, in the emergency and care services), but also indirect (close and knowledge affected by the attack, specific repercussions in the local context, forced changes in the organization of work). It is therefore all hospital professionals, medical students (external, internal) and paramedical students who will be involved in the study.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

804

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Nice, France, 06000
        • Nice hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The staff

  • From the establishments of the Nice University Hospital: Hôpital Pasteur, Hôpital l' Archet, Hôpital de Cimiez, Hôpital St Roch, Unité centrale de production or UCP, Hôpital de Tende.
  • From the Lenval Hospital building: staff of the Nice CHU-Lenval Children's Hospital, and staff of the Lenval Foundation.
  • Students (external from M1 onwards, i. e. the 4th year, and interns) enrolled in Nice-Sophia Antipolis Faculty of Medicine.

Description

  • inclusion criteria: hospital staff Whether or not directly involved in the attack of 14 July 2016.
  • exclusion criteria: non hospital staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
questionnaire about health impact
Time Frame: 1 year
document the health impact of these events and provide useful information for the care arrangements for the populations involved and in the event of a new attack.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2017

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 17-PP-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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