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Characterization of Medical Student Burnout Using Remote Physiologic Monitoring

Primary Purpose

Wellness, Burnout, Remote Monitoring

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WHOOP strap 4.0 (full data access)
WHOOP strap 4.0 (partial data access)
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Wellness focused on measuring WHOOP strap 4.0

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sidney Kimmel Medical College at Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

REM sleep hours, nightly
REM sleep hours will be measured nightly by the WHOOP strap 4.0.
Deep sleep hours, nightly
Deep sleep hours will be measured nightly by the WHOOP strap 4.0.
Resting heart rate, nightly
Resting heart rate will be measured nightly by the WHOOP strap 4.0.
Heart rate variability, nightly
Heart rate variability will be measured nightly by the WHOOP strap 4.0.
Respiration rate, nightly
Respiration rate will be measured nightly by the WHOOP strap 4.0.
Pulse oximetry, nightly
Pulse oximetry will be measured nightly by the WHOOP strap 4.0.
Body temperature, nightly
Body temperature will be measured nightly by the WHOOP strap 4.0.
Average duty hours per week
Duty hours will be self-reported every week
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.
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).
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.

Full Information

First Posted
August 18, 2022
Last Updated
August 23, 2022
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05510102
Brief Title
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
Official Title
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
February 22, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wellness, Burnout, Remote Monitoring
Keywords
WHOOP strap 4.0

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to a treatment group (full remote monitoring data) versus a control arm (blinded data).
Masking
Investigator
Masking Description
Investigators are blinded to subject intervention group (data blinded versus data unblinded)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Subjects will have full remote monitoring data access throughout the entirety of the study (6 months).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
WHOOP strap 4.0 (full data access)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
WHOOP strap 4.0 (partial data access)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Total sleep hours per night
Description
Sleep (hours per night) will be objectively measured nightly.
Time Frame
180 days
Title
Medical Student Well-Being Index (MSWBI)
Description
The MSWBI consists of 7 items, scored 0-7, with lower scores indicative of better medical student wellbeing. This survey will be administered biweekly.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
REM sleep hours, nightly
Description
REM sleep hours will be measured nightly by the WHOOP strap 4.0.
Time Frame
180 days
Title
Deep sleep hours, nightly
Description
Deep sleep hours will be measured nightly by the WHOOP strap 4.0.
Time Frame
180 days
Title
Resting heart rate, nightly
Description
Resting heart rate will be measured nightly by the WHOOP strap 4.0.
Time Frame
180 days
Title
Heart rate variability, nightly
Description
Heart rate variability will be measured nightly by the WHOOP strap 4.0.
Time Frame
180 days
Title
Respiration rate, nightly
Description
Respiration rate will be measured nightly by the WHOOP strap 4.0.
Time Frame
180 days
Title
Pulse oximetry, nightly
Description
Pulse oximetry will be measured nightly by the WHOOP strap 4.0.
Time Frame
180 days
Title
Body temperature, nightly
Description
Body temperature will be measured nightly by the WHOOP strap 4.0.
Time Frame
180 days
Title
Average duty hours per week
Description
Duty hours will be self-reported every week
Time Frame
180 days
Title
Perceived Stress Scale-4
Description
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.
Time Frame
180 days
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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).
Time Frame
180 days
Title
Scores on shelf examinations
Description
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.
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Hajduczok, MD
Organizational Affiliation
Thomas Jefferson University Hospital, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Medical College at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Characterization of Medical Student Burnout Using Remote Physiologic Monitoring

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