NCT04422418

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 3, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

June 3, 2020

Last Update Submit

November 1, 2020

Conditions

Cardiovascular Risk FactorBurnoutImmune Deficiency

Keywords

PandemicsHealthcare professionalsBurnoutCardiovascular risk

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months

    baseline, 2-3 months, 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • not willing to complete written consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

RECRUITING

Mediclinic

Abu Dhabi, United Arab Emirates

RECRUITING

Sheikh Khalifa Medical City

Abu Dhabi, United Arab Emirates

RECRUITING

Sheikh Shakhbout Medical City

Abu Dhabi, United Arab Emirates

RECRUITING

Related Publications (8)

  • 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.

    PMID: 28491040BACKGROUND

  • 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.

    PMID: 26196167BACKGROUND

  • 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.

    PMID: 25634206BACKGROUND

  • 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.

    PMID: 26562047BACKGROUND

  • 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.

    PMID: 29145946BACKGROUND

  • 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.

    PMID: 31420958BACKGROUND

  • 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.

    PMID: 35444572DERIVED

  • 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.

    PMID: 33415114DERIVED

MeSH Terms

Conditions

Burnout, PsychologicalImmunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorImmune System Diseases

Study Officials

  • Wael Almahmeed, MD

    Cleveland Clinic Abu Dhabi

    STUDY CHAIR

Central Study Contacts

Ovidiu C Baltatu, MD PhD

CONTACT

‭+971 2 810 9797ovidiu.baltatu@ku.ac.ae

Hashel Al Tunaiji, MD MSc

CONTACT

+971 50 635 5002dr.tunaiji@ymail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 9, 2020

Study Start

July 1, 2020

Primary Completion

December 14, 2020

Study Completion

December 31, 2020

Last Updated

November 3, 2020

Record last verified: 2020-06

Locations

AE(4)