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Trial record 1 of 1 for:    NCT04385121
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Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection (Familles-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04385121
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : July 21, 2020
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date April 16, 2020
First Posted Date May 12, 2020
Last Update Posted Date July 21, 2020
Actual Study Start Date April 16, 2020
Actual Primary Completion Date April 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2020)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection
Official Title Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Family members of COVID+ patient
  • Covid-19
  • Stress Disorders, Post-Traumatic
  • Anxiety
  • Depression
Intervention Other: Questionnary
Family member's will answer the questionnaires by phone
Study Groups/Cohorts Not Provided
Publications * Cattelan J, Castellano S, Merdji H, Audusseau J, Claude B, Feuillassier L, Cunat S, Astrié 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 11, 2020)
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Actual Primary Completion Date April 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Julie HELMS +33
Contact: Ferhat MEZIANI +33
Listed Location Countries France
Removed Location Countries  
Administrative Information
NCT Number NCT04385121
Other Study ID Numbers 7761
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Principal Investigator: Julie HELMS CHU de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date July 2020