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Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients (HAD-Covid)

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ClinicalTrials.gov Identifier: NCT04430049
Recruitment Status : Not yet recruiting
First Posted : June 12, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period.

Condition or disease Intervention/treatment
Covid-19 Family Members Critical Illness Procedure: Covid ICU containment measures

Detailed Description:

Observational multicenter study

Two groups are compared:

  • restrictive visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2020
  • open visit group. Enrollment during a no Covid period without restrictive visitation: March to June 2021 The primary objective is to compare the Hospital Anxiety and Depression Scale (HADS) for relative at 3 months after the ICU patient discharge between the two groups The secondary objectives are
  • to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3 months after the ICU patient discharge between the two groups
  • to compare the prevalence of significant symptoms of both anxiety and depression for relative at 3 months after the ICU patient discharge between the two groups
  • to compare the prevalence of significant PTSD-related symptoms for relative at 3 months after the ICU patient discharge between the two groups
  • to identify the factor associated with significant symptoms of both anxiety and depression
  • to identify the factor associated with significant PTSD-related symptoms

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients
Estimated Study Start Date : June 22, 2020
Estimated Primary Completion Date : October 22, 2021
Estimated Study Completion Date : January 22, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
restrictive visitation group
relatives cannot visit ICU patient during Covid pandemic period in France
Procedure: Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU

open visitation group
relatives can visit ICU patient during no Covid period in France



Primary Outcome Measures :
  1. Anxiety [ Time Frame: at 3 months ]

    Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed 3 months after the ICU discharge of patient.

    HADS ranges from 0 to 42; higher scores indicate worse symptoms.


  2. Depression [ Time Frame: at 3 months ]

    Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed 3 months after the ICU discharge of patient.

    HADS ranges from 0 to 42; higher scores indicate worse symptoms.



Secondary Outcome Measures :
  1. post-traumatic stress disorder [ Time Frame: at 3 months ]

    Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed 3 months after the ICU discharge of patient.

    IES-R ranges from 0 to 88; higher scores indicate worse symptoms




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Relative of patient who was admitted in ICU and treated with mechanical ventilation or non-invasive ventilation or high flow oxygen or amine administration during 24hours at least.
Criteria

Inclusion Criteria:

  • Relative of patient who was admitted in ICU and treated with mechanical ventilation or non-invasive ventilation or high flow oxygen or amine administration during 24hours at least.

Exclusion Criteria:

  • Relative who declines the enrollment

Information from the National Library of Medicine

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): NCT04430049


Contacts
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Contact: Lise Laclautre +33473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
University hospital, Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63000
Contact: Lise Laclautre    0373754963    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Alexandre Lautrette, MD, PhD         
Sub-Investigator: Thierry Gillard, MD         
Sub-Investigator: Anne Médard, MD         
Sub-Investigator: Russel Chabanne, MD         
Sub-Investigator: Sophie Cayot, MD         
Sub-Investigator: Emmanuel Futier, MD,PhD         
Sub-Investigator: Jean-Etienne Bazin, MD, PhD         
CH Aurillac
Aurillac, France, 15000
Principal Investigator: Marie-Hélène Hausermann, MD         
CH Cannes
Cannes, France, 06150
Principal Investigator: Pierre-Marie Bertrand, MD         
Centre Jean Perrin
Clermont-Ferrand, France, 63000
Principal Investigator: Nathanael Einsemann         
CH Grenoble
Grenoble, France, 38000
CH Le Puy-en-Velay
Le Puy-en-Velay, France, 43000
Principal Investigator: Christophe Leroy, MD         
University hopistal, Lyon
Lyon, France, 69000
CH Moulins
Moulins, France, 03000
Principal Investigator: Luc Jarrige, MD         
CH Périgueux
Périgueux, France, 24000
Principal Investigator: Edouard Soum, MD         
CH Rodez
Rodez, France, 12000
Principal Investigator: Arnaud Delahaye, MD         
CH Vichy
Vichy, France, 03200
Principal Investigator: Ramin Ravan, MD         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04430049    
Other Study ID Numbers: 2020 HAD-Covid
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Covid-19
Family
Anxiety
Depression
Post-traumatic stress disorder
Intensive Care Unit
Visitation
Additional relevant MeSH terms:
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Critical Illness
Depression
Behavioral Symptoms
Disease Attributes
Pathologic Processes