NCT05513339

Brief Summary

A reliable method for monitoring sleep, stress, and burnout among cardiology fellows 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 21 Cardiology Fellows Thomas Jefferson University Hospital 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
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

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
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 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 22, 2022

Conditions

WellnessBurnoutSleep DeprivationExecutive Function

Keywords

WHOOP strap 4.0Remote Monitoring

Outcome Measures

Primary Outcomes (2)

  • Total sleep hours per night

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

    180 days

  • Executive function test (Stroop test), daily

    The Stroop test demonstrates cognitive interference where a delay in the reaction time of a task occurs due to a mismatch in stimuli. A basic task that demonstrates this effect occurs when there is a mismatch between the name of a color (e.g. "blue" or "red") and the color it is printed on (i.e the word "red" printed in blue ink instead of red ink). When asked to name the color of the word it takes longer and is more prone to errors than when the color of the ink matches the name of the color. The test consists of 3 labels, each displaying the name of a color (not necessarily tinted in the color which they denote). The subject is tasked to tap on the appropriate label at the bottom, whose text denotes the ink color of the top label. The total score is the number of correct answers in 60 seconds (+1), minus the number of incorrect answers (-1). Scores may range from 0-60, with mean scores in the range of 10-20. The stroop test will be performed daily (every morning).

    180 days, measured following each 24 hour call shift (weekly)

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 (1)

Cardiology Fellows

Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)

Device: WHOOP strap 4.0

Interventions

WHOOP strap 4.0DEVICE

Subjects will wear the WHOOP strap 4.0 for continuous physiologic monitoring.

Cardiology Fellows

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)

You may qualify if:

  • Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)
  • 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)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Burnout, PsychologicalSleep Deprivation

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Alexander Hajduczok, MD

    Thomas Jefferson University Hospital, Department of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Hajduczok, MD

CONTACT

(215) 955-5050alexander.hajduczok@jefferson.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 24, 2022

Study Start

September 15, 2022

Primary Completion

March 15, 2023

Study Completion

April 15, 2023

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)