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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 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 330 participants.

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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.

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2020-06-29
Est. Completion 2021-06-15

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT04476914

The ClinicalTrials.gov registry entry for NCT04476914 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT04476914 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.