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

NCT ID: NCT04430049

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

811 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-22

Study Completion Date

2022-11-09

Brief Summary

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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)

Detailed Description

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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

Conditions

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Covid-19 Family Members Critical Illness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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no visitation group

relatives cannot visit ICU patient during Covid pandemic period in France

Covid ICU containment measures

Intervention Type PROCEDURE

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

Covid ICU containment measures

Intervention Type PROCEDURE

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

Covid ICU containment measures

Intervention Type PROCEDURE

The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU

Interventions

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Covid ICU containment measures

The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status

CH Aurillac

Aurillac, , France

Site Status

CH Cannes

Cannes, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

CH Grenoble

Grenoble, , France

Site Status

CH Le Puy-en-Velay

Le Puy-en-Velay, , France

Site Status

University hopistal, Lyon

Lyon, , France

Site Status

CH Moulins

Moulins, , France

Site Status

CH Périgueux

Périgueux, , France

Site Status

CH Rodez

Rodez, , France

Site Status

CH Vichy

Vichy, , France

Site Status

Countries

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France

Other Identifiers

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2020 HAD-Covid

Identifier Type: -

Identifier Source: org_study_id

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