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

NCT ID: NCT04422418

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Risk Factor Burnout Immune Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zayed Military Hospital

OTHER_GOV

Sponsor Role collaborator

Abu Dhabi University

UNKNOWN

Sponsor Role collaborator

Cleveland Clinic Abu Dhabi

OTHER

Sponsor Role collaborator

Sheikh Khalifa Medical City

OTHER

Sponsor Role collaborator

Sheikh Shakhbout Medical City

OTHER

Sponsor Role collaborator

Mediclinic Middle East

INDUSTRY

Sponsor Role collaborator

Myriad Global Solutions

UNKNOWN

Sponsor Role collaborator

Khalifa University for Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wael Almahmeed, MD

Role: STUDY_CHAIR

Cleveland Clinic Abu Dhabi

Locations

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Cleveland Clinic Abu Dhabi

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Mediclinic

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Sheikh Khalifa Medical City

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Sheikh Shakhbout Medical City

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Ovidiu C Baltatu, MD PhD

Role: CONTACT

‭+971 2 810 9797

Hashel Al Tunaiji, MD MSc

Role: CONTACT

+971 50 635 5002

Facility Contacts

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Wael Almahmeed, MD

Role: primary

Ahmad Mounir, MD

Role: primary

Seema El Khider Nour, MD

Role: primary

Nadya Matroushi, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28491040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26196167 (View on PubMed)

da Silva ELP, 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.

Reference Type BACKGROUND
PMID: 25634206 (View on PubMed)

Gomez-Pardo E, Fernandez-Alvira JM, Vilanova M, Haro D, Martinez R, Carvajal I, Carral V, Rodriguez C, de Miguel M, Bodega P, Santos-Beneit G, Penalvo JL, Marina I, Perez-Farinos 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.

Reference Type BACKGROUND
PMID: 26562047 (View on PubMed)

Fernandez-Alvira JM, Fuster V, Pocock S, Sanz J, Fernandez-Friera L, Laclaustra M, Fernandez-Jimenez R, Mendiguren J, Fernandez-Ortiz A, Ibanez 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.

Reference Type BACKGROUND
PMID: 29145946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31420958 (View on PubMed)

Alameri F, Aldaheri N, Almesmari S, Basaloum M, Albeshr NA, Simsekler MCE, Ugwuoke NV, Dalkilinc M, Al Qubaisi M, Campos LA, Almahmeed W, Alefishat E, Al Tunaiji H, Baltatu OC. Burnout and Cardiovascular Risk in Healthcare Professionals During the COVID-19 Pandemic. Front Psychiatry. 2022 Apr 4;13:867233. doi: 10.3389/fpsyt.2022.867233. eCollection 2022.

Reference Type DERIVED
PMID: 35444572 (View on PubMed)

Al Tunaiji H, Al Qubaisi M, Dalkilinc M, Campos LA, Ugwuoke NV, Alefishat E, Aloum L, Ross R, Almahmeed W, Baltatu OC. Impact of COVID-19 Pandemic Burnout on Cardiovascular Risk in Healthcare Professionals Study Protocol: A Multicenter Exploratory Longitudinal Study. Front Med (Lausanne). 2020 Dec 22;7:571057. doi: 10.3389/fmed.2020.571057. eCollection 2020.

Reference Type DERIVED
PMID: 33415114 (View on PubMed)

Other Identifiers

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CPRA-2020-034

Identifier Type: -

Identifier Source: org_study_id