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

Completed

• Conditions: Covid-19; Critical Illness; Family Members
• Interventions: Procedure: Covid ICU containment measures

• Registration Number: NCT04430049
• Lead Sponsor: 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 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

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 Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Study Start: 2020-06-22
• Primary Completion: 2022-11-09
• Study Completion: 2022-11-09
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 811

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
open visitation group	Covid ICU containment measures	relatives can visit ICU patient during no Covid period in France
no visitation group	Covid ICU containment measures	relatives cannot visit ICU patient during Covid pandemic period in France
restrictive visitation group	Covid ICU containment measures	relatives have restriction to visit ICU patient during Covid pandemic period in France

Primary Outcome Measures

Name	Time	Method
Anxiety	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.
Depression	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.

Secondary Outcome Measures

Name	Time	Method
post-traumatic stress disorder	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

Trial Locations

Locations (11)

University hospital, Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France

CH Cannes; 🇫🇷 Cannes, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

CH Aurillac; 🇫🇷 Aurillac, France

CH Grenoble; 🇫🇷 Grenoble, France

CH Moulins; 🇫🇷 Moulins, France

University hopistal, Lyon; 🇫🇷 Lyon, France

CH Le Puy-en-Velay; 🇫🇷 Le Puy-en-Velay, France

CH Périgueux; 🇫🇷 Périgueux, France

CH Rodez; 🇫🇷 Rodez, France

CH Vichy; 🇫🇷 Vichy, France