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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04385121
Other study ID # 7761
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 16, 2020
Est. completion date May 15, 2020

Study information

Verified date July 2022
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date May 15, 2020
Est. primary completion date April 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
France Les Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)) 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) 3 months
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