Clinical trial NCT04872049: Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care Unit
Official title: Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Unit
SARS-CoV2
Keywords: SARS-CoV-2
Post-traumatic stress
Anxiety
Depression
Covid-19
Intensive-care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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;

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of post-traumatic stress at 1 year
timeFrame: 12 months from hospitalization
Secondary outcomes:
measure: Level of depression at 1 year
timeFrame: 12 months from hospitalization
measure: Perceived interest of the proposed communication tools at 1 year
timeFrame: 12 months from hospitalization
measure: Level of quality of life at 1 year
timeFrame: 12 months from hospitalization
Other outcomes:
Locations:
city: Paris
country: France
facility: GH Pitié Salpêtrière - Charles Foix
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claire FAZILLEAU
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Arthur Dr JAMES, MD
role: PRINCIPAL_INVESTIGATOR
References: