Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers

Post-traumatic Stress Disorder Clinical Trial

— BURDENCOV  

Official title:

"Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04341519
• Other study ID #: APHP200389
• Status: Recruiting
• Start date: April 6, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nancy KENTISH-BARNES, PhD
• Phone: 142499995
• Email: nancy.kentish[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1464
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients:

• Age>18y

• Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic

• Having received invasive or noninvasive mechanical ventilation

• Non-opposition to participate to the telephone interviews.

Family members:

• Age>18y

• Non-opposition to participate to the telephone interviews

• One family member per patient: the family member the most implicated in the patient's care

Healthcare providers:

• All nurses and physicians (including those in training) in the participating ICUs during the COVID-19 pandemic

Exclusion Criteria:

• Patients:

• Language barrier to be able to respond to the telephone interview

• Cognitive disorders disabling patients to respond to the telephone interview

• Person under legal protection (1121-8 of CSP, Public Health Code) Failure to obtain the non-opposition

Family members:

• Language barrier to be able to respond to the telephone interview

• Person under legal protection (1121-8 of CSP, Public Health Code)

• Failure to obtain the non-opposition

Healthcare providers:

Failure to obtain the non-opposition

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Pneumonia
• Post-traumatic Stress Disorder
• Severe Acute Respiratory Syndrome
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• PTSD
family members: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days Patients: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days
• Burnout
Symptoms of burnout as assessed by the Maslash Burnout Inventory

Locations

Country	Name	City	State
France	Cochin	Paris
France	Pitié Salpetrière	Paris
France	Saint-Louis Hospital	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Family members sup 22	Proportion of Family members with IES-R> 22 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 of corresponding patient. It si a scale ranging from 0 to 88.; Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411	90 days
Secondary	PTSD Family members	Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)	90 days
Secondary	PTSD Patients	Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)	90 days
Secondary	PTSD healthcare providers	Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)	2 months after official end of the Covid-19 peak
Secondary	HADS Family members	Among Family members Symptoms of anxiety and depression using the HADS scale	90 days
Secondary	HADS Patients	Among Patients Symptoms of anxiety and depression using the HADS scale	90 days
Secondary	SF36 Patients	Among Patients Mental and physical health-related quality of life as assessed by the SF36	90 days
Secondary	Questionnaire Family members	Among Family members Questionnaire describing their experience of the patient's ICU hospitalization	90 days
Secondary	Questionnaire Patients	Among Patients Questionnaire describing their experience of the patient's ICU hospitalization	90 days
Secondary	Questionnaire healthcare providers	Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization	2 months after official end of the Covid-19 peak
Secondary	MBI healthcare providers	Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers	2 months after official end of the Covid-19 peak
Secondary	Karasec instrument healthcare providers	Job Strain as assessed by the Karasec instrument	2 months after official end of the Covid-19 peak