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

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Family Members; Critical Illness; Covid-19

Treatments: Procedure: Covid ICU containment measures

Study type: Observational

Funder types: Other

Identifiers

NCT04430049

2020 HAD-Covid

Details and patient eligibility

About

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)

Full 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

Enrollment: 811 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

811 participants in 3 patient groups

no visitation group

Description:

relatives cannot visit ICU patient during Covid pandemic period in France

Treatment:

Procedure: Covid ICU containment measures

restrictive visitation group

Description:

relatives have restriction to visit ICU patient during Covid pandemic period in France

Treatment:

Procedure: Covid ICU containment measures

open visitation group

Description:

relatives can visit ICU patient during no Covid period in France

Treatment:

Procedure: Covid ICU containment measures