- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05510102
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Sidney Kimmel Medical College at Thomas Jefferson University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Alexander Hajduczok, MD, Thomas Jefferson University Hospital, Department of Cardiology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21D.754
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Burnout
-
Shengjing HospitalActive, not recruitingCareer Burnout | Student BurnoutChina
-
Wroclaw University of Health and Sport SciencesUniversity of Silesia in Katowice; Jan Dlugosz University in CzestochowaCompleted
-
Region SkaneLund University; Swedish Council for Working Life and Social Research; County...CompletedProfessional BurnoutSweden
-
University of PadovaUniversity of ChileCompleted
-
University Hospital, Basel, SwitzerlandCompleted
-
Firstbeat Technologies OyTampere University; University of Jyvaskyla; Aisti Health OyActive, not recruitingOccupational Stress | Occupational BurnoutFinland
-
University Diego PortalesInstituto de Seguridad del Trabajo, ChileRecruitingBurnout | Burnout, Caregiver | Parental BurnoutChile
-
Colleen J KleinRecruitingJob Stress | Professional BurnoutUnited States
-
Fondazione Don Carlo Gnocchi OnlusCompleted
-
Mayo ClinicNational Institute of Nursing Research (NINR)Enrolling by invitation
Clinical Trials on WHOOP strap 4.0 (full data access)
-
Thomas Jefferson UniversityNot yet recruitingBurnout | Sleep Deprivation | Executive Function | WellnessUnited States
-
Yale UniversityWHOOP Inc.; ZS Associates, Inc.Completed