NCT05510102

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 18, 2022

Last Update Submit

August 23, 2022

Conditions

WellnessBurnoutRemote Monitoring

Keywords

WHOOP strap 4.0

Outcome Measures

Primary Outcomes (2)

  • Total sleep hours per night

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

    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.

    180 days

Secondary Outcomes (11)

  • REM sleep hours, nightly

    180 days

  • Deep sleep hours, nightly

    180 days

  • Resting heart rate, nightly

    180 days

  • Heart rate variability, nightly

    180 days

  • Respiration rate, nightly

    180 days

  • +6 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

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

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).

Device: WHOOP strap 4.0 (partial data access)

Interventions

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).

Treatment group
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).

Control group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Allergies, contraindications, or unwillingness to wear a wrist device for the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Medical College at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Alexander Hajduczok, MD

    Thomas Jefferson University Hospital, Department of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigators are blinded to subject intervention group (data blinded versus data unblinded)
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Subjects will be randomized to a treatment group (full remote monitoring data) versus a control arm (blinded data).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 22, 2022

Study Start

August 22, 2022

Primary Completion

February 22, 2023

Study Completion

April 1, 2023

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)