WellnessNCT05510102
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
A study testing WHOOP strap 4.0 (full data access) and WHOOP strap 4.0 (partial data access) in people with Wellness and Burnout, run by Thomas Jefferson University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Wellness, Burnout, Remote Monitoring
- What is being tested?
- WHOOP strap 4.0 (full data access) and WHOOP strap 4.0 (partial data access)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergies, contraindications, or unwillingness to wear a wrist device for the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Medical College at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the 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.
- Conditions
- Wellness, Burnout, Remote Monitoring
- Being tested
- WHOOP strap 4.0 (full data access), WHOOP strap 4.0 (partial data access)
- Keywords
- WHOOP strap 4.0
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOOP strap 4.0 (full data access)Device
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)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subjects will have full remote monitoring data access throughout the entirety of the study (6 months). Receives: Device: WHOOP strap 4.0 (full data access) |
| Control group | Active comparator | 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). Receives: Device: WHOOP strap 4.0 (partial data access) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep hours per night
Sleep (hours per night) will be objectively measured nightly.
Measured: 180 days
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.
Measured: 180 days
Secondary outcomes (11)
REM sleep hours, nightly
REM sleep hours will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Deep sleep hours, nightly
Deep sleep hours will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Resting heart rate, nightly
Resting heart rate will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Heart rate variability, nightly
Heart rate variability will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Respiration rate, nightly
Respiration rate will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Pulse oximetry, nightly
Pulse oximetry will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Body temperature, nightly
Body temperature will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Average duty hours per week
Duty hours will be self-reported every week
Measured: 180 days
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.
Measured: 180 days
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).
Measured: 180 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start22 Aug 2022
- Primary completion22 Feb 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellnessStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to a treatment group (full remote monitoring data) versus a control arm (blinded data).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Hajduczok, Thomas Jefferson University
- Investigators
- Alexander Hajduczok, MD, Principal investigator, Thomas Jefferson University Hospital, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510102
- Sponsor's protocol ID
- 21D.754
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
- ClinicalTrials.gov ID
- NCT05510102
- Acronym / sponsor ID
- 21D.754
- Conditions
- Wellness, Burnout, Remote Monitoring
- Keywords
- WHOOP strap 4.0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 22 Feb 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomized to a treatment group (full remote monitoring data) versus a control arm (blinded data).
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: WHOOP strap 4.0 (full data access)Subjects will have full remote monitoring data access throughout the entirety of the study (6 months). |
| Control group | Active comparator | Device: WHOOP strap 4.0 (partial data access)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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Allergies, contraindications, or unwillingness to wear a wrist device for the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Treatment group |
| 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). | Device | Control group |
Primary outcome
Total sleep hours per night
Time frame: 180 days
Sleep (hours per night) will be objectively measured nightly.
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.
11 secondary outcomes
REM sleep hours, nightly
Time frame: 180 days
Deep sleep hours, nightly
Time frame: 180 days
Resting heart rate, nightly
Time frame: 180 days
Heart rate variability, nightly
Time frame: 180 days
Respiration rate, nightly
Time frame: 180 days
Pulse oximetry, nightly
Time frame: 180 days
Body temperature, nightly
Time frame: 180 days
Average duty hours per week
Time frame: 180 days
Perceived Stress Scale-4
Time frame: 180 days
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 180 days
Scores on shelf examinations
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Hajduczok, MD principal investigator
Thomas Jefferson University Hospital, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHOOP strap 4.0 (full data access) and WHOOP strap 4.0 (partial data access) in people with Wellness and Burnout, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep hours per night (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.