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

Completed

• Conditions: Covid-19; Anxiety; Depression; Stress Disorders, Post-Traumatic

• Registration Number: NCT04385121
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-16
• Primary Completion: 2020-04-16
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Completion: 2020-05-15
• Last Update Submitted: 2022-06-30
• Status Verified: 2022-07
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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))	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)

Trial Locations

Locations (1)

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France