Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care Unit

NCT04872049 | Unknown

• 2 other identifiers: APHP2004502020-A03430-39
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged. During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way. The hypothesis is that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of the patients and their relatives.

Conditions

Intensive Care Unit; SARS-CoV2

Keywords

SARS-CoV-2; Post-traumatic stress; Anxiety; Depression; Covid-19; Intensive-care

Outcome Measures

Primary Outcomes (1)

• Prevalence of post-traumatic stress at 1 year

  Prevalence of post-traumatic stress in patients treated in intensive care at 1 year diagnosed with an IES-r\> 33 depending on whether they are SARS-CoV-2 positive or not. (IES-r: Impact of Event Scale - Revised scale, minimum value: 0, maximum value: 88, higher score indicates a worse outcome)

  12 months from hospitalization

Secondary Outcomes (3)

• Level of depression at 1 year

  12 months from hospitalization

• Perceived interest of the proposed communication tools at 1 year

  12 months from hospitalization

• Level of quality of life at 1 year

  12 months from hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted more than 2 days (48 hours) in Intensive care unit between 01/01/2020 and 06/30/2020i, infected or not with SARS-CoV-2;

You may qualify if:

• Major patients (above 18 years old)
• Admitted in intensive care unit
• Hospitalized more than 2 days (48 hours)
• Between 01/01/2020 and 06/30/2020
• Whether SARS-CoV-2 positive or negative

You may not qualify if:

• Minor patient
• Protected major (under safeguardship, curatorship or guardianship)
• Patient opposition

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

GH Pitié Salpêtrière - Charles Foix

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Claire FAZILLEAU

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Arthur Dr JAMES, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: April 27, 2021
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)