HAD-Covid: Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Observational multicenter study
Three groups are compared:
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no visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2020
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restrictive visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2021
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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
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to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after the ICU patient discharge between the three groups
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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
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to compare the prevalence of significant PTSD-related symptoms for relative at 3-6 months after the ICU patient discharge between the three groups
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to identify the factor associated with significant symptoms of both anxiety and depression
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to identify the factor associated with significant PTSD-related symptoms
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| no visitation group relatives cannot visit ICU patient during Covid pandemic period in France |
Procedure: Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
|
| restrictive visitation group relatives have restriction to visit ICU patient during Covid pandemic period in France |
Procedure: Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
|
| open visitation group relatives can visit ICU patient during no Covid period in France |
Procedure: Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospital, Clermont-Ferrand | Clermont-Ferrand | Auvergne | France | 63000 |
| 2 | CH Aurillac | Aurillac | France | 15000 | |
| 3 | CH Cannes | Cannes | France | 06150 | |
| 4 | Centre Jean Perrin | Clermont-Ferrand | France | 63000 | |
| 5 | CH Grenoble | Grenoble | France | 38000 | |
| 6 | CH Le Puy-en-Velay | Le Puy-en-Velay | France | 43000 | |
| 7 | University hopistal, Lyon | Lyon | France | 69000 | |
| 8 | CH Moulins | Moulins | France | 03000 | |
| 9 | CH Périgueux | Périgueux | France | 24000 | |
| 10 | CH Rodez | Rodez | France | 12000 | |
| 11 | CH Vichy | Vichy | France | 03200 |
Sponsors and Collaborators
- University Hospital, Clermont-Ferrand
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020 HAD-Covid