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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04476914
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
University of Washington
Tulane University
University of Vermont
Penn State University
Columbia University
South Shore Hospital
Evergreen Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease
Respiratory Failure SARS-CoV 2 Corona Virus Infection Post Intensive Care Unit Syndrome Family Members Post Traumatic Stress Disorder Anxiety Depression

Detailed Description:

The study aims to define the prevalence of PICS-F in the study population 3-4 months after ICU admission of patient, specifically symptoms of PTSD as the primary outcome, and symptoms of depression and anxiety as secondary outcomes. The study hypothesizes prevalence will be higher than seen in other studies.

An additional aim is to identify predisposing or mitigating exposures for PICS-F. The study hypothesizes that increased psychological symptoms will be associated less exposure to virtual patient visits (tablet/video conferencing), higher number of patient comorbidities (using the Charleston comorbidity index), preexisting family member psychological conditions.

The study also plans to evaluate the association between family perception of quality of communication or decision-making using items from the validated Family Satisfaction in the ICU (FS-ICU) and psychological symptoms. The study hypothesizes that the quality of communication and decision-making will be associated with lower psychological symptoms.

Finally, the plan is to, using qualitative methods, explore and describe family members' stress, experiences with communication with healthcare providers and their satisfaction with ICU care while being physically distant from their loved ones. The aim is to use qualitative findings about family members' experiences to contextualize and explain results differences in stress, satisfaction and communication quality between low vs high PICS-F scores.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort
Family Member
Family members of ICU patients admitted with respiratory failure from COVID-19



Primary Outcome Measures :
  1. Symptoms of Post-Traumatic Stress Disorder (PTSD) [ Time Frame: 90-120 days after admission of patient to the ICU ]
    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


Secondary Outcome Measures :
  1. Symptoms of Anxiety [ Time Frame: 90-120 days after admission of patient to the ICU ]
    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

  2. Symptoms of Depression [ Time Frame: 90-120 days after admission of patient to the ICU ]
    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

  3. Family Satisfaction with Communication and Decision Making [ Time Frame: 90-120 days after admission of patient to the ICU ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be consenting family members of COVID-19 positive patients who are admitted to the intensive care unit with respiratory failure
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476914


Contacts
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Contact: Timothy H Amass, MD, ScM 2038935300 timothy.amass@cuanschutz.edu
Contact: Priscilla Priscilla Armstrong priscilla.armstrong@gmail.com

Locations
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United States, Colorado
Eastern Colorado Veterans Affairs Health Care System, University Of Colorado Active, not recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Trevor Lane, MD       trevor.lane@cuanschutz.edu   
Principal Investigator: Marc Moss, MD         
Sub-Investigator: Trevor Lane, MD         
United States, Louisiana
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Karin Halvorsen, MD         
Principal Investigator: Karin Halvorson, MD         
Sub-Investigator: Rachel Hammer, MD         
Sub-Investigator: Jennifer Chiurco, MD         
United States, Massachusetts
Brigham and Women's Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Masami Kelly         
Principal Investigator: Zara Cooper, MD         
Sub-Investigator: Rachel Bernacki         
Sub-Investigator: Masami Kelly, MA         
South Shore Medical Center Recruiting
Weymouth, Massachusetts, United States, 02910
Contact: Nick Csikesz         
Principal Investigator: Nick Csikesz, MD         
Sub-Investigator: Don McGuirl, BA         
United States, New York
Columbia Milstein and Allen Hospitals Recruiting
New York, New York, United States, 10034
Contact: May Hua, MD         
Principal Investigator: May Hua, MD         
Sub-Investigator: Matt Baldwin, MD         
Sub-Investigator: Sarah Rhoads, MD         
Sub-Investigator: Melanie Ambler, MSc         
Sub-Investigator: Laura Fonseca         
United States, Pennsylvania
Penn State Hershey Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Pamela Witt       pwitt@pennstatehealth.psu.edu   
Principal Investigator: Lauren Jodi Van Scoy, MD         
Sub-Investigator: Sarah Hochendoner, MD         
Sub-Investigator: Pamela Witt         
United States, Vermont
University of Vermont Medical Center Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Priscilla Armstrong       priscilla.armstrong@gmail.com   
Principal Investigator: J. Randall Curtis, MD, MPH         
Sponsors and Collaborators
University of Colorado, Denver
University of Washington
Tulane University
University of Vermont
Penn State University
Columbia University
South Shore Hospital
Evergreen Hospital
Brigham and Women's Hospital
Publications:
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed on 3/30/2020

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04476914    
Other Study ID Numbers: 20-1021
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Insufficiency
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections