NCT04738747

Brief Summary

Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Status
withdrawn

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

January 29, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

August 2, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 29, 2021

Last Update Submit

July 29, 2021

Conditions

BurnoutStressSleep DeprivationWellness

Keywords

BurnoutFitness Tracker

Outcome Measures

Primary Outcomes (6)

  • Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion

    MBI items are scored using a 7 level frequency ratings from "never" to "daily" - emotional exhaustion (9 items) - Higher scores indicate higher burnout (worse) than lower scores (better)

    Baseline through Month 6

  • Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion

    MBI items are scored using a 7 level frequency ratings from "never" to "daily" - emotional exhaustion (9 items) - Higher scores indicate higher burnout (worse) than lower scores (better)

    Baseline through Month 3

  • Change in Maslach Burnout Inventory (MBI) Scores - depersonalization

    MBI items are scored using a 7 level frequency ratings from "never" to "daily" - depersonalization (5 items) - Higher scores indicate higher burnout (worse) than lower scores (better)

    Baseline through Month 3

  • Change in Maslach Burnout Inventory (MBI) Scores - depersonalization

    MBI items are scored using a 7 level frequency ratings from "never" to "daily" - depersonalization (5 items) - Higher scores indicate higher burnout (worse) than lower scores (better)

    Baseline through Month 6

  • Change in Maslach Burnout Inventory (MBI) Scores - personal achievement

    MBI items are scored using a 7 level frequency ratings from "never" to "daily" - personal achievement (8 items) - Higher scores indicate higher burnout (worse) than lower scores (better)

    Baseline through Month 3

  • Change in Maslach Burnout Inventory (MBI) Scores - personal achievement

    MBI items are scored using a 7 level frequency ratings from "never" to "daily" - personal achievement (8 items) - Higher scores indicate higher burnout (worse) than lower scores (better)

    Baseline through Month 6

Study Arms (2)

Study arm (receive a WHOOP device)

EXPERIMENTAL

Participants randomized to the WHOOP group will be given WHOOP wrist and arm bands to wear 24/7 after an orientation on their use

Behavioral: WHOOP fitness tracker

Control arm (no intervention)

NO INTERVENTION

The control group will not have any intervention

Interventions

WHOOP fitness trackerBEHAVIORAL

WHOOP is a device that uses a wristband or arm band to track heart rate, heart rate variability (HRV), and sleep to calculate proprietary strain and recovery scores for its users. Heart rate variability is an important metric for correlation with acute stress

Study arm (receive a WHOOP device)

Eligibility Criteria

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

You may qualify if:

  • All attending and resident Otolaryngologists at Wake Forest Baptist Health

You may not qualify if:

  • Users of a WHOOP device currently
  • Current interns will be excluded given they do not work with the Otolaryngology team the whole year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Lyndsay Madden, DO

    Wake Forest Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Study the impact of the WHOOP fitness tracker
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 4, 2021

Study Start

July 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

August 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share