Depression Clinical Trial
Official title:
Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units
NCT number | NCT04476914 |
Other study ID # | 20-1021 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 29, 2020 |
Est. completion date | June 15, 2021 |
Verified date | June 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 330 |
Est. completion date | June 15, 2021 |
Est. primary completion date | June 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Family members of COVID-19 positive patients admitted to the Intensive Care Unit with respiratory failure Exclusion Criteria: - Family members will be excluded if they: are under 18 or unable to complete the survey's due to language barriers |
Country | Name | City | State |
---|---|---|---|
United States | Eastern Colorado Veterans Affairs Health Care System, University Of Colorado | Aurora | Colorado |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | Brigham and Women's Medical Center | Boston | Massachusetts |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Penn State Hershey Milton S Hershey Medical Center | Hershey | Pennsylvania |
United States | Tulane Medical Center | New Orleans | Louisiana |
United States | Columbia Milstein and Allen Hospitals | New York | New York |
United States | University of Washington | Seattle | Washington |
United States | South Shore Medical Center | Weymouth | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Brigham and Women's Hospital, Columbia University, Evergreen Hospital, Penn State University, South Shore Hospital, Tulane University, University of Vermont, University of Washington |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptoms of Post-Traumatic Stress Disorder (PTSD) | 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 | 90-120 days after admission of patient to the ICU | |
Secondary | Symptoms of Anxiety | Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety | 90-120 days after admission of patient to the ICU | |
Secondary | Symptoms of Depression | Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression | 90-120 days after admission of patient to the ICU | |
Secondary | Family Satisfaction with Communication and Decision Making | Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication | 90-120 days after admission of patient to the ICU |
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