Ignite Creation Date:
2024-05-06 @ 2:32 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04341519
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-04-07
Brief Title:
Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia Their Relatives and Their Healthcare Providers
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia Their Relatives and Their Healthcare Providers Impact Psychologique de lépidémie COVID-19 Chez Les Patients Familles et Soignants de Reanimation BURDENCOV
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BURDENCOV
Brief Summary:
Coronavirus disease 2019 COVID-19 is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 The infection is highly contagious requiring restrictive and stressful measures for patients family members and ICU healthcare providers To avoid contagion patient isolation has become the rule For patients these measures add stress to the ICU environment and deprive them of unrestricted family visits Family members are not only left with fear but also many unanswered questions In end-of-life situations many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process The impact of exclusion or limited inclusion certainly needs to be explored Moreover ICU caregivers are having to face new challenges and to work in a unknown situation juggling with both professional issues such as increased workload working longer hours and safety issues and personal issues such as child care and transport as well as family transmission of the virus
The main objective of this study is to demonstrate that the COVID-19 pandemic as compared to seasonal flu and community acquired pneumonia significantly increases post-traumatic stress disorder PTSD in family members of critically ill patients
PTSD-related symptoms will be assessed in family members using the IES-R impact of event scale revised during a telephone interview 90 days after ICU discharge The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events It will be compared across the three groups COVID-19 FLU and CAP
The main objective of this study is to demonstrate that the COVID-19 pandemic as compared to seasonal flu and community acquired pneumonia significantly increases post-traumatic stress disorder PTSD in family members of critically ill patients
PTSD-related symptoms will be assessed in family members using the IES-R impact of event scale revised during a telephone interview 90 days after ICU discharge The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events It will be compared across the three groups COVID-19 FLU and CAP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None