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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    250
  • sponsor
    University of Colorado, Denver
Updated on 27 June 2021
depression
anxiety
respiratory distress
acute respiratory distress
covid-19
SARS
coronavirus
depressed mood
post-traumatic stress disorder
traumatic stress disorder
acute respiratory distress syndrome
coronavirus infection

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 syndromefamily (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.

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.

Details
Condition Coronavirus Infection, Family, Respiratory Failure, Endogenous depression, Depression, Post-Traumatic Stress Disorder, Coronavirus, ANXIETY NEUROSIS, Anxiety, Depression (Major/Severe), Anxiety Disorders (Pediatric), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Post-Traumatic Stress Disorders, Depression (Treatment-Resistant), Generalized Anxiety Disorder (GAD), Depressed, Generalized Anxiety Disorder (GAD - Pediatric), Corona Virus Infection, Anxiety Symptoms, Anxiety Disorders, Post Intensive Care Unit Syndrome, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, depressive disorder, PTSD, anxiety disorder, depressed mood, miserable, depressive disorders, anxious, Sars Cov 2
Clinical Study IdentifierNCT04476914
SponsorUniversity of Colorado, Denver
Last Modified on27 June 2021

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