Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU

Completed

Conditions studied: Respiratory Failure, SARS-CoV 2, Corona Virus Infection, Post Intensive Care Unit Syndrome, Family Members, Post Traumatic Stress Disorder, Anxiety, Depression

In brief

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.

Key facts

Study ID

NCT04476914

Run by

University of Colorado, Denver

People needed

330

Starts

2020-06-29

Expected to finish

2021-06-15

Last updated by the study team

2021-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Family members of COVID-19 positive patients admitted to the Intensive Care Unit with respiratory failure

You may not qualify if…

• Family members will be excluded if they: are under 18 or unable to complete the survey's due to language barriers

Where it is running

• Eastern Colorado Veterans Affairs Health Care System, University Of Colorado — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Brigham and Women's Medical Center — Boston, Massachusetts, United States
• South Shore Medical Center — Weymouth, Massachusetts, United States
• Columbia Milstein and Allen Hospitals — New York, New York, United States
• Penn State Hershey Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Vermont Medical Center — Burlington, Vermont, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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