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Smartwatch and Physician Well-Being

Primary Purpose

Professional Burnout

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartwatch
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Professional Burnout

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physician

Exclusion Criteria:

  • non physicians

Sites / Locations

  • Lotte DyrbyeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Smart Watch, then no intervention

No intervention, then Smart Watch

Arm Description

Physicians will be asked to wear a Smartwatch for 6 months, and then will be monitored for the following 6 months without wearing a Smartwatch. Physicians will complete surveys about their experiences

Physicians will be monitored for the first 6 months without wearing a Smartwatch, and then will be asked to wear a Smartwatch for the following 6 months. Physicians will complete surveys about their experiences

Outcomes

Primary Outcome Measures

Burnout
The Maslach Burnout Inventory measures emotional exhaustion, depersonalization, and low sense of personal accomplishment. Possible scores range from 0-27 (emotional exhaustion subscale), 0-10 (depersonalization subscale), and 0-40 (personal accomplishment subscale). Higher scores on the emotional exhaustion and depersonalization subscales and lower scores on the personal accomplishment subscale indicates worse outcome.

Secondary Outcome Measures

Physician Well-Being Index
The Physician Well-Being Index measures multiple dimensions of distress (burnout, fatigue, quality of life, stress) and satisfaction with work-life integration and meaning in work. The total score ranges from -2 to 9, with higher scores indicating a greater degree of distress, lower meaning in work, and less satisfaction with work-life integration.

Full Information

First Posted
July 14, 2022
Last Updated
May 23, 2023
Sponsor
University of Colorado, Denver
Collaborators
Physicians Foundation, Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05463250
Brief Title
Smartwatch and Physician Well-Being
Official Title
Smartwatch and Physician Well-being: Are Wearables Part of the Solution?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Physicians Foundation, Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The prevalence of burnout and other forms of distress among physicians is alarmingly high. This clinical trial is being conducted to learn more about if wearing a Smartwatch and having access to its data improves physicians' sense of well-being and if data measured from Smartwatches contain a 'signal' that predicts well-being
Detailed Description
We will conduct a randomized controlled trail to evaluate if wearing a Smartwatch improves overall well-being among physicians, and if so, in which dimension of well-being (e.g., fatigue, stress, overall quality of life, burnout). Additionally, we will explore if data from Smartwatches can predict subsequent well-being among physicians. Study Aims: To determine if wearing a Smartwatch and having access to its physiological data (e.g., sleep, step count, activity, breathing reminders) improves well-being, and if so which well-being dimensions. To determine whether continuous physiological measures (measured from Smartwatches) contain a 'signal' that predicts physician well-being, and if so in which dimensions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Professional Burnout

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smart Watch, then no intervention
Arm Type
Experimental
Arm Description
Physicians will be asked to wear a Smartwatch for 6 months, and then will be monitored for the following 6 months without wearing a Smartwatch. Physicians will complete surveys about their experiences
Arm Title
No intervention, then Smart Watch
Arm Type
Experimental
Arm Description
Physicians will be monitored for the first 6 months without wearing a Smartwatch, and then will be asked to wear a Smartwatch for the following 6 months. Physicians will complete surveys about their experiences
Intervention Type
Device
Intervention Name(s)
Smartwatch
Intervention Description
Wearing a smartwatch and having access to its data
Primary Outcome Measure Information:
Title
Burnout
Description
The Maslach Burnout Inventory measures emotional exhaustion, depersonalization, and low sense of personal accomplishment. Possible scores range from 0-27 (emotional exhaustion subscale), 0-10 (depersonalization subscale), and 0-40 (personal accomplishment subscale). Higher scores on the emotional exhaustion and depersonalization subscales and lower scores on the personal accomplishment subscale indicates worse outcome.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Physician Well-Being Index
Description
The Physician Well-Being Index measures multiple dimensions of distress (burnout, fatigue, quality of life, stress) and satisfaction with work-life integration and meaning in work. The total score ranges from -2 to 9, with higher scores indicating a greater degree of distress, lower meaning in work, and less satisfaction with work-life integration.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physician Exclusion Criteria: non physicians
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lotte Dyrbye, MD MHPE
Phone
3037244982
Email
liselotte.dyrbye@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liselotte N Dyrbye, MD MHPE
Organizational Affiliation
University of Colorado School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lotte Dyrbye
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lotte N Dyrbye, MD
Email
liselotte.dyrbye@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Smartwatch and Physician Well-Being

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