Impact of Burnout on Cardiovascular and Immune Biomarkers in Healthcare Professionals - Covid-19 Pandemic in Abu Dhabi

Cardiovascular Risk Factor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422418
• Other study ID #: CPRA-2020-034
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: Khalifa University for Science and Technology
• Contact: Ovidiu C Baltatu, MD PhD
• Phone: ?+971 2 810 9797
• Email: ovidiu.baltatu[@]ku.ac.ae
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological
• Cardiovascular Risk Factor
• Immune Deficiency
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
United Arab Emirates	Cleveland Clinic Abu Dhabi	Abu Dhabi
United Arab Emirates	Mediclinic	Abu Dhabi
United Arab Emirates	Sheikh Khalifa Medical City	Abu Dhabi
United Arab Emirates	Sheikh Shakhbout Medical City	Abu Dhabi

Sponsors (8)

Lead Sponsor	Collaborator
Khalifa University for Science and Technology	Abu Dhabi University, Cleveland Clinic Abu Dhabi, Mediclinic Middle East, Myriad Global Solutions, Sheikh Khalifa Medical City, Sheikh Shakhbout Medical City, Zayed Military Hospital

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (7)

da Silva EL, Pereira R, Reis LN, Pereira VL Jr, Campos LA, Wessel N, Baltatu OC. Heart rate detrended fluctuation indexes as estimate of obstructive sleep apnea severity. Medicine (Baltimore). 2015 Jan;94(4):e516. doi: 10.1097/MD.0000000000000516. — View Citation

Fernández-Alvira JM, Fuster V, Pocock S, Sanz J, Fernández-Friera L, Laclaustra M, Fernández-Jiménez R, Mendiguren J, Fernández-Ortiz A, Ibáñez B, Bueno H. Predicting Subclinical Atherosclerosis in Low-Risk Individuals: Ideal Cardiovascular Health Score and Fuster-BEWAT Score. J Am Coll Cardiol. 2017 Nov 14;70(20):2463-2473. doi: 10.1016/j.jacc.2017.09.032. — View Citation

Gómez-Pardo E, Fernández-Alvira JM, Vilanova M, Haro D, Martínez R, Carvajal I, Carral V, Rodríguez C, de Miguel M, Bodega P, Santos-Beneit G, Peñalvo JL, Marina I, Pérez-Farinós N, Dal Re M, Villar C, Robledo T, Vedanthan R, Bansilal S, Fuster V. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program. J Am Coll Cardiol. 2016 Feb 9;67(5):476-85. doi: 10.1016/j.jacc.2015.10.033. Epub 2015 Nov 9. Erratum in: J Am Coll Cardiol. 2016 Mar 22;67(11):1385. — View Citation

Green-McKenzie J, Somasundaram P, Lawler T, O'Hara E, Shofer FS. Prevalence of Burnout in Occupational and Environmental Medicine Physicians in the United States. J Occup Environ Med. 2020 May 12. doi: 10.1097/JOM.0000000000001913. [Epub ahead of print] — View Citation

Henriksen A, Grimsgaard S, Horsch A, Hartvigsen G, Hopstock L. Validity of the Polar M430 Activity Monitor in Free-Living Conditions: Validation Study. JMIR Form Res. 2019 Aug 16;3(3):e14438. doi: 10.2196/14438. — View Citation

Pereira VL Jr, Dobre M, Dos Santos SG, Fuzatti JS, Oliveira CR, Campos LA, Brateanu A, Baltatu OC. Association between Carotid Intima Media Thickness and Heart Rate Variability in Adults at Increased Cardiovascular Risk. Front Physiol. 2017 Apr 26;8:248. doi: 10.3389/fphys.2017.00248. eCollection 2017. — View Citation

Pinheiro Ade O, Pereira VL Jr, Baltatu OC, Campos LA. Cardiac autonomic dysfunction in elderly women with myocardial infarction. Curr Med Res Opin. 2015;31(10):1849-54. doi: 10.1185/03007995.2015.1074065. Epub 2015 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 2-3 months, 6 months
Primary	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.	baseline, 2-3 months, 6 months
Primary	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.	baseline, 2-3 months, 6 months
Primary	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.	baseline, 2-3 months, 6 months
Primary	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).	baseline, 2-3 months, 6 months
Primary	Change from Baseline Immune Dysfunction at 2-3 months and 6 months	Classification of the immune function will be screened.	baseline, 2-3 months, 6 months
Secondary	Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months	Submaximal field test and maximal oxygen consumption (VO2, mL/kg/min).	baseline, 2-3 months, 6 months