Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU
NCT04476914 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330
Last updated 2021-06-22
Summary
Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.
Conditions
- Respiratory Failure
- SARS-CoV 2
- Corona Virus Infection
- Post Intensive Care Unit Syndrome
- Family Members
- Post Traumatic Stress Disorder
- Anxiety
- Depression
Sponsors & Collaborators
- collaborator OTHER
-
Tulane University
collaborator OTHER -
University of Vermont
collaborator OTHER -
Penn State University
collaborator OTHER - collaborator OTHER
-
South Shore Hospital
collaborator OTHER -
Evergreen Hospital
collaborator UNKNOWN -
Brigham and Women's Hospital
collaborator OTHER -
University of Colorado, Denver
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-06-29
- Primary Completion
- 2021-06-15
- Completion
- 2021-06-15
Countries
- United States
Study Locations
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