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OpenTrials
Completed

NCT Number: NCT04385121

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnary

Other

Family member's will answer the questionnaires by phone

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: Familles-COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 12, 2020
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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