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

Covid-19 Clinical Trial

— HAD-Covid  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430049
• Other study ID #: 2020 HAD-Covid
• Status: Completed
• Start date: June 22, 2020
• Est. completion date: November 9, 2022

Study information

• Verified date: June 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 811
• Est. completion date: November 9, 2022
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Critical Illness
• Depression
• Family Members

Intervention

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

Locations

Country	Name	City	State
France	CH Aurillac	Aurillac
France	CH Cannes	Cannes
France	Centre Jean Perrin	Clermont-Ferrand
France	University hospital, Clermont-Ferrand	Clermont-Ferrand	Auvergne
France	CH Grenoble	Grenoble
France	CH Le Puy-en-Velay	Le Puy-en-Velay
France	University hopistal, Lyon	Lyon
France	CH Moulins	Moulins
France	CH Périgueux	Périgueux
France	CH Rodez	Rodez
France	CH Vichy	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	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
Primary	Depression	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	post-traumatic stress disorder	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