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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: SARS-CoV2; Intensive Care Unit

Detailed Description

The stay in the ICU is a complex and often traumatic experience for patients. Patients often develop psychiatric disorders such as anxiety, depression or post-traumatic stress disorder after an ICU stay. These symptoms can be prolonged over time, resulting in a decrease in quality of life and a potential cost in care.

In the epidemic context of the COVID crisis, the presence of family members in the intensive care unit was reduced to its most extreme portion, with sometimes an almost total impossibility of visiting a loved one. This situation, although it has become less strict, has lasted for a long time. The patient can only exchange with them with difficulty, despite the extremely trying situation that is resuscitation. Moreover, there is a stress factor linked to the infectious risk for the relatives and for the relatives with regard to COVID-19, in particular within the framework of family clusters with sometimes several hospitalized subjects within the same family.

Of course, means of communication have been put in place with relatives, but these means do not seem to be equivalent to the presence of one's relatives.

The investigators therefore hypothesize 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 patients and their relatives.

• Study Type: Observational
• Enrollment (Anticipated): 264

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75013
      • GH Pitié Salpêtrière - Charles Foix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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;

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of depression at 1 year	Assessed by the Center for Epidemiologic Studies Depression scale (CES-D, minimum value: 0, maximum value: 60, higher score indicates a worse outcome)	12 months from hospitalization
Perceived interest of the proposed communication tools at 1 year	Semi-structured interviews	12 months from hospitalization
Level of quality of life at 1 year	Assessed by EQ-5D (EuroQol 5Dimension scale, minimum value: 0, maximum value: 100, higher score indicates a better outcome)	12 months from hospitalization

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Claire FAZILLEAU, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Arthur Dr JAMES, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Anticipated): October 27, 2021
• Study Completion (Anticipated): October 27, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Depression; SARS-CoV-2; Anxiety; Covid-19; Post-traumatic stress; Intensive-care
• Other Study ID Numbers: APHP200450; 2020-A03430-39 (Other Identifier: IDRCB)

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