Characterization of Medical Student Burnout Using Remote Physiologic Monitoring

Sponsor
Thomas Jefferson University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05510102
Collaborator
(none)
50
1
2
7.3
6.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: WHOOP strap 4.0 (full data access)
  • Device: WHOOP strap 4.0 (partial data access)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects will be randomized to a treatment group (full remote monitoring data) versus a control arm (blinded data).Subjects will be randomized to a treatment group (full remote monitoring data) versus a control arm (blinded data).
Masking:
Single (Investigator)
Masking Description:
Investigators are blinded to subject intervention group (data blinded versus data unblinded)
Primary Purpose:
Diagnostic
Official Title:
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
Actual Study Start Date :
Aug 22, 2022
Anticipated Primary Completion Date :
Feb 22, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Subjects will have full remote monitoring data access throughout the entirety of the study (6 months).

Device: WHOOP strap 4.0 (full data access)
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).

Device: WHOOP strap 4.0 (partial data access)
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).

Outcome Measures

Primary Outcome Measures

  1. Total sleep hours per night [180 days]

    Sleep (hours per night) will be objectively measured nightly.

  2. Medical Student Well-Being Index (MSWBI) [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.

Secondary Outcome Measures

  1. REM sleep hours, nightly [180 days]

    REM sleep hours will be measured nightly by the WHOOP strap 4.0.

  2. Deep sleep hours, nightly [180 days]

    Deep sleep hours will be measured nightly by the WHOOP strap 4.0.

  3. Resting heart rate, nightly [180 days]

    Resting heart rate will be measured nightly by the WHOOP strap 4.0.

  4. Heart rate variability, nightly [180 days]

    Heart rate variability will be measured nightly by the WHOOP strap 4.0.

  5. Respiration rate, nightly [180 days]

    Respiration rate will be measured nightly by the WHOOP strap 4.0.

  6. Pulse oximetry, nightly [180 days]

    Pulse oximetry will be measured nightly by the WHOOP strap 4.0.

  7. Body temperature, nightly [180 days]

    Body temperature will be measured nightly by the WHOOP strap 4.0.

  8. Average duty hours per week [180 days]

    Duty hours will be self-reported every week

  9. Perceived Stress Scale-4 [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.

  10. Patient Health Questionnaire-9 (PHQ-9) [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).

  11. Scores on shelf examinations [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexander Hajduczok, Principal Investigator, Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT05510102
Other Study ID Numbers:
  • 21D.754
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Alexander Hajduczok, Principal Investigator, Thomas Jefferson University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022