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Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection (Familles-COVID)

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ClinicalTrials.gov Identifier: NCT04385121
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

The hospitalization of a patient in intensive care is a traumatic experience for his family members.

With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit.

At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time.

The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.


Condition or disease Intervention/treatment
Covid-19 Stress Disorders, Post-Traumatic Anxiety Depression Other: Questionnary

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection
Actual Study Start Date : April 16, 2020
Actual Primary Completion Date : April 16, 2020
Estimated Study Completion Date : March 2021

Intervention Details:
  • Other: Questionnary
    Family member's will answer the questionnaires by phone


Primary Outcome Measures :
  1. Existence of a post-intensive care syndrome-family ((combined score of the HAD ( Hospital Anxiety and Dépression scale) and IES-R ( Impact of Event Scale-Revised) questionnaires)) [ Time Frame: 3 months ]
    An overall score of 19 or more indicates a major depressive episode (HAD) and a total score of 22 as in favor of significant symptoms of acute stress (IES-R)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Family members of COVID+ patient
Criteria

Inclusion Criteria:

  • Family member of a Covid-19 positive patient hospitalized in Intensive Care Unit who gave his oral agreement following the communication of the notice of non-opposition.
  • A patient is considered to be Covid + if the RT-PCR is positive OR if characteristic images are taken with a chest scanner.
  • The family member included in the study is preferably the patient's support person. In the absence of an expression of the patient's will, he is the close referent designated by the family as an interlocutor.

Exclusion Criteria:

  • Difficulties in understanding French

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385121


Contacts
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Contact: Julie HELMS +33 3.69.55.04.34 Julie.helms@chru-strasbourg.fr
Contact: Ferhat MEZIANI +33 3.69.55.10.24 Ferhat.meziani@chru-strasbourg.fr

Locations
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France
Les Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Julie HELMS    +33 3.69.55.04.34    Julie.helms@chru-strasbourg.fr   
Sub-Investigator: Ferhat MEZIANI         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Julie HELMS CHU de Strasbourg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04385121    
Other Study ID Numbers: 7761
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
COVID-19
Psychological impact
Family members
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders