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

Depression Clinical Trial

— Familles-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385121
• Other study ID #: 7761
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Covid-19
• Depression
• Stress Disorders, Post-Traumatic

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