An observational study in Cardiovascular Risk Factor, Burnout and Immune Deficiency, sponsored by Khalifa University for Science and Technology. Status unknown at 4 sites in United Arab Emirates. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Khalifa University for Science and Technology · Observational
The main objective of our project is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare with different levels of exposure to the COVID-19 pandemic.
Introduction: The coronavirus disease 2019 (COVID-19) pandemic has created new and unpredictable challenges for healthcare systems. Healthcare professionals are heavily affected by this rapidly changing situation. They may experience psychological burden, especially nurses, women, and frontline health care professionals directly engaged in the diagnosis, treatment, and care for patients with COVID-19. The objective of this study is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare professionals with different levels of exposure to the COVID-19 pandemic. The effects of the pandemic work burden on psychological, cardiovascular and immune biomarkers will be stratified per level of exposure to the COVID-19 pandemic, positive diagnosis to COVID-19, profession, sex, age and already existent cardiovascular risk.
Methods: A STROBE compliant, blended exploratory study involving online and onsite approach with wearable monitoring will be implemented. A planned random probability sample of residents, staff physicians, nurses and auxiliary healthcare professionals will be recruited from both inpatient and outpatient medicine services will be stratified by exposure to COVID-19 pandemic (frontline versus second line). In a first step, will be an online recruitment with e-consent and e-survey with Maslach Burnout Inventory, Fuster-BEWAT score and sociodemographic characteristics, and planning for onsite visit; in a second step, will be a setup for wearable monitoring of heart rate, actimetry and sleep quality together with blood sampling for immune biomarkers; steps 1 \& 2 will be repeated at 2-3 months, 6 months. Power BI \& Tableau will be used for data visualization purposes, while the front-end data capture application will be used for data collection and will be built using specific survey/questionnaire related tools for healthcare usage data linkage.
Ethics and dissemination: Institutional Review Board approval has been obtained from Khalifa University (protocol # CPRA-2020-034) and Department of Health-Abu Dhabi (protocol # CVDC-20-05/2020-8). Data analysis, release of results and publication of manuscripts are scheduled to start in early 2021. Data and findings may be useful to healthcare policymakers for developing preventive strategies to reduce or prevent burnout, cardiovascular risk and immune dysfunction.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 200 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Khalifa University for Science and Technology as lead sponsor.
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Residents, staff physicians, nurses and auxiliary healthcare professionals (adult males and females over 18 years) from both inpatient and outpatient medicine services
Exclusion Criteria:
Change from Baseline Burnout at 2-3 months and 6 months
Burnout - through self-reported stress and burnout thoughts, beliefs, emotions, behavior related to Covid-19 using Maslach Burnout Inventory. Maslach Burnout Inventory - is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day.
Time frame: baseline, 2-3 months, 6 months
Change from Baseline Cardiovascular Risk Cardiovascular Risk Through Heart Rate Variability Markers at 2-3 months and 6 months
Data is collected through wearable monitoring technology. Cardiovascular risk through monitoring of heart rate variability (HRV) markers. Changes of heart rate variability (HRV) reflecting cardiac autonomic dysfunction are associated with greater risks for cardiac morbidity and mortality.
Time frame: baseline, 2-3 months, 6 months
Change from Baseline Through Actigraphy at 2-3 months and 6 months
Data is collected through wearable monitoring technology. Actigraphy data is collected in 1 min epochs using the zero-crossing modes.
Time frame: baseline, 2-3 months, 6 months
Change from Baseline Through Sleep Quality at 2-3 months and 6 months
Data is collected through wearable monitoring technology. Sleep efficiency is defined as the proportion of the estimated sleep periods spent asleep. Sleep latency is the length of time taken to fall asleep, calculated as the time between 'lights off' to the first period of 3 min of consecutive epochs scored as sleep.
Time frame: baseline, 2-3 months, 6 months
Change from Baseline Cardiovascular Risk Through Fuster-BEWAT score at 2-3 months and 6 months
Cardiovascular risk through Fuster-BEWAT score. The Fuster-BEWAT score will be analyzed as a continuous variable with total score ranging from 0 to 15 points. Additionally, each component will be categorized as ideal (3) or nonideal (0 to 2), and participants will be classified as having poor, intermediate, or ideal cardiovascular health based on the total number of ideal components (0 to 1 = poor, 2 to 3 = intermediate, 4 to 5 = ideal) (Fernández-Alvira et al., 2017).
Time frame: baseline, 2-3 months, 6 months
Change from Baseline Immune Dysfunction at 2-3 months and 6 months
Classification of the immune function will be screened.
Time frame: baseline, 2-3 months, 6 months
Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months
Submaximal field test and maximal oxygen consumption (VO2, mL/kg/min).
Time frame: baseline, 2-3 months, 6 months
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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