Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients
HAD-Covid
Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients
1 other identifier
observational
811
1 country
11
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2022
CompletedFebruary 8, 2023
June 1, 2020
2.4 years
June 10, 2020
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
post-traumatic stress disorder
between 3 and 6 months
Study Arms (3)
no visitation group
relatives cannot visit ICU patient during Covid pandemic period in France
restrictive visitation group
relatives have restriction to visit ICU patient during Covid pandemic period in France
open visitation group
relatives can visit ICU patient during no Covid period in France
Interventions
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
Eligibility Criteria
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.
You may qualify if:
- Relative of patient who was admitted in ICU and treated with invasive mechanical ventilation administration during 24hours at least.
You may not qualify if:
- Relative who declines the enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University hospital, Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63000, France
CH Aurillac
Aurillac, 15000, France
CH Cannes
Cannes, 06150, France
Centre Jean Perrin
Clermont-Ferrand, 63000, France
CH Grenoble
Grenoble, 38000, France
CH Le Puy-en-Velay
Le Puy-en-Velay, 43000, France
University hopistal, Lyon
Lyon, 69000, France
CH Moulins
Moulins, 03000, France
CH Périgueux
Périgueux, 24000, France
CH Rodez
Rodez, 12000, France
CH Vichy
Vichy, 03200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 12, 2020
Study Start
June 22, 2020
Primary Completion
November 9, 2022
Study Completion
November 9, 2022
Last Updated
February 8, 2023
Record last verified: 2020-06