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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05463250
Other study ID # 22-0799
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date May 2024

Study information

Verified date December 2023
Source University of Colorado, Denver
Contact Lotte Dyrbye, MD MHPE
Phone 3037244982
Email liselotte.dyrbye@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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: 1. 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. 2. To determine whether continuous physiological measures (measured from Smartwatches) contain a 'signal' that predicts physician well-being, and if so in which dimensions.


Recruitment information / eligibility

Status Recruiting
Enrollment 184
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Physician Exclusion Criteria: - non physicians

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Smartwatch
Wearing a smartwatch and having access to its data

Locations

Country Name City State
United States Lotte Dyrbye Aurora Colorado

Sponsors (3)

Lead Sponsor Collaborator
University of Colorado, Denver Mayo Clinic, Physicians Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 12 months
Secondary 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. Up to 12 months
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