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

February 6, 2023 updated by: University Hospital, Clermont-Ferrand

Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients

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 in 2020 and in 2021. 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 (2020 and 2021) with those no Covid period (2022)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Observational multicenter study

Three groups are compared:

  • no visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2020
  • restrictive visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2021
  • open visit group. Enrollment during a no Covid period without restrictive visitation: March to June 2022 The primary objective is to compare the Hospital Anxiety and Depression Scale (HADS) for relative at 3-6 months after the ICU patient discharge between the three groups The secondary objectives are
  • to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after the ICU patient discharge between the three groups
  • to compare the prevalence of significant symptoms of both anxiety and depression for relative at 3-6 months after the ICU patient discharge between the three groups
  • to compare the prevalence of significant PTSD-related symptoms for relative at 3-6 months after the ICU patient discharge between the three groups
  • to identify the factor associated with significant symptoms of both anxiety and depression
  • to identify the factor associated with significant PTSD-related symptoms

Study Type

Observational

Enrollment (Actual)

811

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aurillac, France, 15000
        • CH Aurillac
      • Cannes, France, 06150
        • Ch Cannes
      • Clermont-Ferrand, France, 63000
        • Centre Jean Perrin
      • Grenoble, France, 38000
        • CH Grenoble
      • Le Puy-en-Velay, France, 43000
        • CH Le Puy-en-Velay
      • Lyon, France, 69000
        • University hopistal, Lyon
      • Moulins, France, 03000
        • Ch Moulins
      • Périgueux, France, 24000
        • CH Périgueux
      • Rodez, France, 12000
        • CH Rodez
      • Vichy, France, 03200
        • CH VICHY
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63000
        • University Hospital, Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders 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.

Description

Inclusion Criteria:

  • Relative of patient who was admitted in ICU and treated with invasive mechanical ventilation administration during 24hours at least.

Exclusion Criteria:

  • Relative who declines the enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no 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
restrictive visitation group
relatives have restriction to 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
Procedure: Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Between 3 and 6 months

Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.

HADS ranges from 0 to 42; higher scores indicate worse symptoms.
Between 3 and 6 months
Depression
Time Frame: Between 3 and 6 months

Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.

HADS ranges from 0 to 42; higher scores indicate worse symptoms.
Between 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-traumatic stress disorder
Time Frame: between 3 and 6 months

Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed between 3 and 6 months after the ICU discharge of patient.

IES-R ranges from 0 to 88; higher scores indicate worse symptoms
between 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 22, 2020

Primary Completion (ACTUAL)

November 9, 2022

Study Completion (ACTUAL)

November 9, 2022

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (ACTUAL)

June 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020 HAD-Covid

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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