Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

14. maj 2021 opdateret af: Assistance Publique - Hôpitaux de Paris

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

Aktiv, ikke rekrutterende

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

Observationel

Tilmelding (Forventet)

264

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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;

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Level of depression at 1 year
Tidsramme: 12 months from hospitalization
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
Tidsramme: 12 months from hospitalization
Semi-structured interviews
12 months from hospitalization
Level of quality of life at 1 year
Tidsramme: 12 months from hospitalization
Assessed by EQ-5D (EuroQol 5Dimension scale, minimum value: 0, maximum value: 100, higher score indicates a better outcome)
12 months from hospitalization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Claire FAZILLEAU, Assistance Publique - Hôpitaux de Paris
  • Ledende efterforsker: Arthur Dr JAMES, MD, Assistance Publique - Hôpitaux de Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. april 2021

Primær færdiggørelse (Forventet)

27. oktober 2021

Studieafslutning (Forventet)

27. oktober 2021

Datoer for studieregistrering

Først indsendt

29. april 2021

Først indsendt, der opfyldte QC-kriterier

29. april 2021

Først opslået (Faktiske)

4. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • APHP200450
  • 2020-A03430-39 (Anden identifikator: IDRCB)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med SARS-CoV-2

3
Abonner