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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04385121|
Recruitment Status : Completed
First Posted : May 12, 2020
Last Update Posted : July 1, 2022
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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.
|Condition or disease||Intervention/treatment|
|Covid-19 Stress Disorders, Post-Traumatic Anxiety Depression||Other: Questionnary|
|Study Type :||Observational|
|Actual Enrollment :||88 participants|
|Official Title:||Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection|
|Actual Study Start Date :||April 16, 2020|
|Actual Primary Completion Date :||April 16, 2020|
|Actual Study Completion Date :||May 15, 2020|
- Other: Questionnary
Family member's will answer the questionnaires by phone
- 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)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- Difficulties in understanding French
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385121
|Les Hôpitaux Universitaires de Strasbourg|
|Strasbourg, France, 67091|
|Principal Investigator:||Julie HELMS||CHU de Strasbourg|
|Responsible Party:||University Hospital, Strasbourg, France|
|Other Study ID Numbers:||
|First Posted:||May 12, 2020 Key Record Dates|
|Last Update Posted:||July 1, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Stress Disorders, Post-Traumatic
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders