- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04872049
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Ile De France
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Paris, Ile De France, Frankrig, 75013
- GH Pitié Salpêtrière - Charles Foix
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tværsnit
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Prevalence of post-traumatic stress at 1 year
Tidsramme: 12 months from hospitalization
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Level of depression at 1 year
Tidsramme: 12 months from hospitalization
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Assessed by the Center for Epidemiologic Studies Depression scale (CES-D, minimum value: 0, maximum value: 60, higher score indicates a worse outcome)
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12 months from hospitalization
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Perceived interest of the proposed communication tools at 1 year
Tidsramme: 12 months from hospitalization
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Semi-structured interviews
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12 months from hospitalization
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Level of quality of life at 1 year
Tidsramme: 12 months from hospitalization
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Assessed by EQ-5D (EuroQol 5Dimension scale, minimum value: 0, maximum value: 100, higher score indicates a better outcome)
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12 months from hospitalization
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Claire FAZILLEAU, Assistance Publique - Hôpitaux de Paris
- Ledende efterforsker: Arthur Dr JAMES, MD, Assistance Publique - Hôpitaux de Paris
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- APHP200450
- 2020-A03430-39 (Anden identifikator: IDRCB)
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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