- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05463250
Smartwatch and Physician Well-Being
December 4, 2023 updated by: University of Colorado, Denver
Smartwatch and Physician Well-being: Are Wearables Part of the Solution?
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
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
184
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lotte Dyrbye, MD MHPE
- Phone Number: 3037244982
- Email: liselotte.dyrbye@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Lotte Dyrbye
-
Contact:
- Lotte N Dyrbye, MD
- Email: liselotte.dyrbye@cuanschutz.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Physician
Exclusion Criteria:
- non physicians
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smart Watch, then no intervention
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
|
Wearing a smartwatch and having access to its data
|
|
Experimental: No intervention, then Smart Watch
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
|
Wearing a smartwatch and having access to its data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Burnout
Time Frame: Up to 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physician Well-Being Index
Time Frame: Up to 12 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Liselotte N Dyrbye, MD MHPE, University of Colorado School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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