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NCT04476914 · ClinicalTrials.gov registry record
Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 330
- Enrollment target
NCT04476914: Completed study, sponsored by University of Colorado, Denver.
NCT04476914 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 330 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04476914 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 330 participants
- Enrollment target
Study 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.
Primary Outcome
Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2021-06-15 |
What the finished NCT04476914 record still lists
NCT04476914 is an observational study that tracks outcomes without assigning an intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04476914 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04476914 about?
NCT04476914 is a clinical study titled "Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU". 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 distres...
What is the current status of trial NCT04476914?
This trial is currently completed. The enrollment target is 330 participants. The study started on 2020-06-29. Estimated completion is 2021-06-15.
Who is sponsoring clinical trial NCT04476914?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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