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

NCT04385121 | Completed

• 1 other identifier: 7761
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID-19; Psychological impact; Family members

Outcome Measures

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))

  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

Interventions

Questionnary OTHER

Family member's will answer the questionnaires by phone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Family members of COVID+ patient

You may qualify if:

• 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.

You may not qualify if:

• Difficulties in understanding French

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• Cattelan J, Castellano S, Merdji H, Audusseau J, Claude B, Feuillassier L, Cunat S, Astrie M, Aquin C, Buis G, Gehant E, Granier A, Kercha H, Le Guillou C, Martin G, Roulot K, Meziani F, Putois O, Helms J. Psychological effects of remote-only communication among reference persons of ICU patients during COVID-19 pandemic. J Intensive Care. 2021 Jan 9;9(1):5. doi: 10.1186/s40560-020-00520-w.

  PMID: 33422153 DERIVED

MeSH Terms

Conditions

COVID-19; Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Julie HELMS

  CHU de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: May 12, 2020
• Study Start: April 16, 2020
• Primary Completion: April 16, 2020
• Study Completion: May 15, 2020
• Last Updated: July 1, 2022

Record last verified: 2022-07

Locations

FR (1)