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ClinicalTrials.gov ID

NCT04341519

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

1,464Estimated

Last Update Posted

Oct 6, 2020Actual

Start Date

Apr 6, 2020Actual

Primary Completion Date

Nov 30, 2020Estimated

Completion Date

Dec 31, 2021Estimated

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"

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).

• Corona Virus Infection
• Post-traumatic Stress Disorder

• PTSD
• Burnout

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

alexandre.demoule@aphp.fr