Clinical trial NCT04430049: Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Family Members
Critical Illness
Keywords: Covid-19
Family
Anxiety
Depression
Post-traumatic stress disorder
Intensive Care Unit
Visitation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 811
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: Between 3 and 6 months
measure: Depression
timeFrame: Between 3 and 6 months
Secondary outcomes:
measure: post-traumatic stress disorder
timeFrame: between 3 and 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University hospital, Clermont-Ferrand
state: Auvergne
city: Aurillac
country: France
facility: CH Aurillac
city: Cannes
country: France
facility: CH Cannes
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Grenoble
country: France
facility: CH Grenoble
city: Le Puy-en-Velay
country: France
facility: CH Le Puy-en-Velay
city: Lyon
country: France
facility: University hopistal, Lyon
city: Moulins
country: France
facility: CH Moulins
city: Périgueux
country: France
facility: CH Périgueux
city: Rodez
country: France
facility: CH Rodez
city: Vichy
country: France
facility: CH Vichy
Study officials:
References: