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Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout

Primary Purpose

Burnout, Stress, Sleep Deprivation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WHOOP fitness tracker
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burnout focused on measuring Burnout, Fitness Tracker

Eligibility Criteria

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

Inclusion Criteria:

  • All attending and resident Otolaryngologists at Wake Forest Baptist Health

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Study arm (receive a WHOOP device)

    Control arm (no intervention)

    Arm Description

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

    The control group will not have any intervention

    Outcomes

    Primary Outcome Measures

    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)
    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)
    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)
    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)
    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)
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 29, 2021
    Last Updated
    July 29, 2021
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04738747
    Brief Title
    Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout
    Official Title
    Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of Grant
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

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

    5. Study Description

    Brief Summary
    Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists
    Detailed Description
    The study will be a randomized controlled trial of attending and resident otolaryngologists who will be randomized to either wearing a WHOOP fitness tracker or a control group. Participants will take two Maslach burnout inventory (MBI) surveys prior to the start of the intervention to set a baseline burnout score, and then at 3 months and 6 months into the study. Baseline cardiac status will also be established by taking a pre-intervention heart rate and blood pressure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burnout, Stress, Sleep Deprivation, Wellness
    Keywords
    Burnout, Fitness Tracker

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Study the impact of the WHOOP fitness tracker
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study arm (receive a WHOOP device)
    Arm Type
    Experimental
    Arm Description
    Participants randomized to the WHOOP group will be given WHOOP wrist and arm bands to wear 24/7 after an orientation on their use
    Arm Title
    Control arm (no intervention)
    Arm Type
    No Intervention
    Arm Description
    The control group will not have any intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    WHOOP fitness tracker
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion
    Description
    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)
    Time Frame
    Baseline through Month 6
    Title
    Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion
    Description
    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)
    Time Frame
    Baseline through Month 3
    Title
    Change in Maslach Burnout Inventory (MBI) Scores - depersonalization
    Description
    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)
    Time Frame
    Baseline through Month 3
    Title
    Change in Maslach Burnout Inventory (MBI) Scores - depersonalization
    Description
    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)
    Time Frame
    Baseline through Month 6
    Title
    Change in Maslach Burnout Inventory (MBI) Scores - personal achievement
    Description
    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)
    Time Frame
    Baseline through Month 3
    Title
    Change in Maslach Burnout Inventory (MBI) Scores - personal achievement
    Description
    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)
    Time Frame
    Baseline through Month 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All attending and resident Otolaryngologists at Wake Forest Baptist Health Exclusion Criteria: Users of a WHOOP device currently Current interns will be excluded given they do not work with the Otolaryngology team the whole year
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lyndsay Madden, DO
    Organizational Affiliation
    Wake Forest Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout

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