Characterization of Medical Student Burnout Using Remote Physiologic Monitoring

Burnout Clinical Trial

Official title:

Characterization of Medical Student Burnout Using Remote Physiologic Monitoring

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05510102
• Other study ID #: 21D.754
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: April 1, 2023
• Est. primary completion date: February 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological
• Remote Monitoring
• Wellness

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Sidney Kimmel Medical College at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep hours per night	Sleep (hours per night) will be objectively measured nightly.	180 days
Primary	Medical Student Well-Being Index (MSWBI)	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	REM sleep hours, nightly	REM sleep hours will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Deep sleep hours, nightly	Deep sleep hours will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Resting heart rate, nightly	Resting heart rate will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Heart rate variability, nightly	Heart rate variability will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Respiration rate, nightly	Respiration rate will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Pulse oximetry, nightly	Pulse oximetry will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Body temperature, nightly	Body temperature will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Average duty hours per week	Duty hours will be self-reported every week	180 days
Secondary	Perceived Stress Scale-4	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
Secondary	Patient Health Questionnaire-9 (PHQ-9)	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
Secondary	Scores on shelf examinations	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