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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04872049
Acronym
FAMILY-COVID
Enrollment
264
Registered
2021-05-04
Start date
2021-04-27
Completion date
2021-10-27
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit, SARS-CoV2

Keywords

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

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of post-traumatic stress at 1 year12 months from hospitalizationPrevalence 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)

Secondary

MeasureTime frameDescription
Level of depression at 1 year12 months from hospitalizationAssessed by the Center for Epidemiologic Studies Depression scale (CES-D, minimum value: 0, maximum value: 60, higher score indicates a worse outcome)
Perceived interest of the proposed communication tools at 1 year12 months from hospitalizationSemi-structured interviews
Level of quality of life at 1 year12 months from hospitalizationAssessed by EQ-5D (EuroQol 5Dimension scale, minimum value: 0, maximum value: 100, higher score indicates a better outcome)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026