Characterization of Medical Student Burnout Using Remote Physiologic Monitoring

August 23, 2022 updated by: Alexander Hajduczok, Thomas Jefferson University
A reliable method for monitoring stress and burnout among medical students is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 50 third-year medical students at 24 Sidney Kimmel Medical College at Thomas Jefferson University for 6 months.

Study Overview

Detailed Description

Aim 1: To determine whether physiologic metrics of sleep and heart rate variability correlate with subjective assessments of medical student wellness in a 6-month period.

Hypothesis: Less total sleep hours will correlate with higher scores for Perceived Stress Scale-4, Medical Student Well-Being Index, and Patient Health Questionnaire-9, but lower heart rate variability will correlate with higher scores on Perceived Stress Scale-4, Medical Student Well Being Index, and Patient Health Questionnaire-9.

Aim 2: To determine whether physiologic metrics of sleep and heart rate variability correlate with performance on shelf examinations for clinical rotations in a 6-month period.

Hypothesis: Less total sleep hours and lower heart rate variability will correlate with poorer performance on shelf examinations.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Medical College at Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Third-year medical student at Thomas Jefferson University
  • ≥18 years of age
  • Actively participating in family medicine, internal medicine, neurology, obstetrics/gynecology, pediatrics, psychiatry, surgery, or emergency medicine rotations
  • Own a smart phone for Bluetooth pairing with WHOOP strap 4.0

Exclusion Criteria:

  • Allergies, contraindications, or unwillingness to wear a wrist device for the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Subjects will have full remote monitoring data access throughout the entirety of the study (6 months).
The WHOOP strap 4.0 provides continuous physiologic data via remote monitoring. Subjects will have full remote monitoring data access throughout the entirety of the study (6 months).
Active Comparator: Control group
Subjects will be blinded to remote monitoring data for the first 3 months of the study followed by an unblinding and full access to remote monitoring data at the 3 month mark (continued for the remainder of the study).
The WHOOP strap 4.0 provides continuous physiologic data via remote monitoring. Subjects will be blinded to remote monitoring data for the first 3 months of the study followed by an unblinding and full access to remote monitoring data at the 3 month mark (continued for the remainder of the study).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sleep hours per night
Time Frame: 180 days
Sleep (hours per night) will be objectively measured nightly.
180 days
Medical Student Well-Being Index (MSWBI)
Time Frame: 180 days
The MSWBI consists of 7 items, scored 0-7, with lower scores indicative of better medical student wellbeing. This survey will be administered biweekly.
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
REM sleep hours, nightly
Time Frame: 180 days
REM sleep hours will be measured nightly by the WHOOP strap 4.0.
180 days
Deep sleep hours, nightly
Time Frame: 180 days
Deep sleep hours will be measured nightly by the WHOOP strap 4.0.
180 days
Resting heart rate, nightly
Time Frame: 180 days
Resting heart rate will be measured nightly by the WHOOP strap 4.0.
180 days
Heart rate variability, nightly
Time Frame: 180 days
Heart rate variability will be measured nightly by the WHOOP strap 4.0.
180 days
Respiration rate, nightly
Time Frame: 180 days
Respiration rate will be measured nightly by the WHOOP strap 4.0.
180 days
Pulse oximetry, nightly
Time Frame: 180 days
Pulse oximetry will be measured nightly by the WHOOP strap 4.0.
180 days
Body temperature, nightly
Time Frame: 180 days
Body temperature will be measured nightly by the WHOOP strap 4.0.
180 days
Average duty hours per week
Time Frame: 180 days
Duty hours will be self-reported every week
180 days
Perceived Stress Scale-4
Time Frame: 180 days
The PSS-4 consists of 4 items that assess perceived stress. The items are scored on a 4-point scale. This survey will be administered biweekly.
180 days
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 180 days
The (Patient Health Questionnaire-9) PHQ-9 consists of 9 items that assess major depressive disorder. This survey will be administered biweekly. It is scored on a 0-27 scale with 27 representing most severe depression (worse outcomes).
180 days
Scores on shelf examinations
Time Frame: 180 days
Subjects will self-report examination scores for shelf exams administered after each clinical rotation. Scores are reported on a 0-100 scale with 100 being the best score possible.
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexander Hajduczok, MD, Thomas Jefferson University Hospital, Department of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2022

Primary Completion (Anticipated)

February 22, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21D.754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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