Clinical trial NCT04422418: Impact of Burnout on Cardiovascular and Immune Biomarkers in Healthcare Professionals - Covid-19 Pandemic in Abu Dhabi
Official title: Multi-Center Prospective Cohort Study: Impact of Burnout on Cardiovascular and Immune Biomarkers Among Frontline Healthcare Professionals During Covid-19 Pandemic in Abu Dhabi Emirate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Risk Factor
Burnout
Immune Deficiency
Keywords: Pandemics
Healthcare professionals
Burnout
Cardiovascular risk
Lead sponsor: Khalifa University for Science and Technology
Sponsor class: OTHER
Collaborators: name: Zayed Military Hospital
name: Abu Dhabi University
name: Cleveland Clinic Abu Dhabi
name: Sheikh Khalifa Medical City
name: Sheikh Shakhbout Medical City
name: Mediclinic Middle East
name: Myriad Global Solutions
First posted: 2020-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents, staff physicians, nurses and auxiliary healthcare professionals (adult males and females over 18 years) from both inpatient and outpatient medicine services

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* all residents, staff physicians, nurses and auxiliary healthcare professionals from both inpatient and outpatient medicine services who agreed to be a part of the study will be provided with heart rate tracking devices to monitor heart rate.

Exclusion Criteria:

* not willing to complete written consent form.

Primary outcomes:
measure: Change from Baseline Burnout at 2-3 months and 6 months
timeFrame: baseline, 2-3 months, 6 months
measure: Change from Baseline Cardiovascular Risk Cardiovascular Risk Through Heart Rate Variability Markers at 2-3 months and 6 months
timeFrame: baseline, 2-3 months, 6 months
measure: Change from Baseline Through Actigraphy at 2-3 months and 6 months
timeFrame: baseline, 2-3 months, 6 months
measure: Change from Baseline Through Sleep Quality at 2-3 months and 6 months
timeFrame: baseline, 2-3 months, 6 months
measure: Change from Baseline Cardiovascular Risk Through Fuster-BEWAT score at 2-3 months and 6 months
timeFrame: baseline, 2-3 months, 6 months
measure: Change from Baseline Immune Dysfunction at 2-3 months and 6 months
timeFrame: baseline, 2-3 months, 6 months
Secondary outcomes:
measure: Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months
timeFrame: baseline, 2-3 months, 6 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi
city: Abu Dhabi
country: United Arab Emirates
facility: Mediclinic
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City
Study officials:
affiliation: Cleveland Clinic Abu Dhabi
name: Wael Almahmeed, MD
role: STUDY_CHAIR
References:
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