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

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ClinicalTrials.gov Identifier: NCT04422418
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Zayed Military Hospital
Abu Dhabi University
Cleveland Clinic Abu Dhabi
Sheikh Khalifa Medical City
Sheikh Shakhbout Medical City
Mediclinic Middle East
Myriad Global Solutions
Information provided by (Responsible Party):
Khalifa University for Science and Technology

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.

Condition or disease
Cardiovascular Risk Factor Burnout Immune Deficiency

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 14, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change from Baseline Burnout at 2-3 months and 6 months [ Time Frame: baseline, 2-3 months, 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.

  2. Change from Baseline Cardiovascular Risk Cardiovascular Risk Through Heart Rate Variability Markers at 2-3 months and 6 months [ Time Frame: baseline, 2-3 months, 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.

  3. Change from Baseline Through Actigraphy at 2-3 months and 6 months [ Time Frame: baseline, 2-3 months, 6 months ]
    Data is collected through wearable monitoring technology. Actigraphy data is collected in 1 min epochs using the zero-crossing modes.

  4. Change from Baseline Through Sleep Quality at 2-3 months and 6 months [ Time Frame: baseline, 2-3 months, 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.

  5. Change from Baseline Cardiovascular Risk Through Fuster-BEWAT score at 2-3 months and 6 months [ Time Frame: baseline, 2-3 months, 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).

  6. Change from Baseline Immune Dysfunction at 2-3 months and 6 months [ Time Frame: baseline, 2-3 months, 6 months ]
    Classification of the immune function will be screened.


Secondary Outcome Measures :
  1. Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months [ Time Frame: baseline, 2-3 months, 6 months ]
    Submaximal field test and maximal oxygen consumption (VO2, mL/kg/min).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

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): NCT04422418


Contacts
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Contact: Ovidiu C Baltatu, MD PhD ‭+971 2 810 9797 ovidiu.baltatu@ku.ac.ae
Contact: Hashel Al Tunaiji, MD MSc +971 50 635 5002 dr.tunaiji@ymail.com

Locations
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United Arab Emirates
Cleveland Clinic Abu Dhabi Recruiting
Abu Dhabi, United Arab Emirates
Contact: Wael Almahmeed, MD       MahmeeW@ClevelandClinicAbuDhabi.ae   
Principal Investigator: Khurram Ali, MD         
Mediclinic Recruiting
Abu Dhabi, United Arab Emirates
Contact: Ahmad Mounir, MD       farah8feb@yahoo.co.uk   
Sheikh Khalifa Medical City Recruiting
Abu Dhabi, United Arab Emirates
Contact: Seema El Khider Nour, MD       snour@seha.ae   
Sheikh Shakhbout Medical City Recruiting
Abu Dhabi, United Arab Emirates
Contact: Nadya Matroushi, MD       nmatroshi@seha.ae   
Sponsors and Collaborators
Khalifa University for Science and Technology
Zayed Military Hospital
Abu Dhabi University
Cleveland Clinic Abu Dhabi
Sheikh Khalifa Medical City
Sheikh Shakhbout Medical City
Mediclinic Middle East
Myriad Global Solutions
Investigators
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Study Chair: Wael Almahmeed, MD Cleveland Clinic Abu Dhabi
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Khalifa University for Science and Technology
ClinicalTrials.gov Identifier: NCT04422418    
Other Study ID Numbers: CPRA-2020-034
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Khalifa University for Science and Technology:
Pandemics
Healthcare professionals
Burnout
Cardiovascular risk
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Immune System Diseases