- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481138
Predicting Burnout in Nurses
August 19, 2023 updated by: William V. Bobo, M.D., Mayo Clinic
Wearable Augmented Prediction of Burnout in Nurses: A Synergy of Engineering, Bioethics, Nursing and Wellness Sciences
The purpose of this study is to develop a technology to predict burnout in RNs by measuring workplace, psychological, and physiological factors experienced by nurses.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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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 62 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Registered Nurses (RNs) at Mayo Clinic from Emergency Department, Intensive Care Units (including neonatal), selected Medical/Surgical units, and Inpatient Psychiatry.
RNs from Inpatient Psychiatry will be recruited only from Mayo Rochester.
Description
Inclusion Criteria:
- Employed as a registered nurse at Mayo Clinic Rochester or Mayo Clinic Florida.
- Primary work assignment is one of the following: medical-surgical units, operating and recovery rooms, emergency room, intensive/cardiac care units, or other special care units (including neonatal intensive care units and newborn nurseries).
- Proficient in written and spoken English.
- Able to provide written informed consent.
Exclusion Criteria:
- Any exception to above criteria.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
|
Self-reported Maslach Burnout Inventory-Human Services Survey (MBI-HSS) assess clinician well-being in dimensions of burnout, engagement, and professional satisfaction.
22-item questionnaire ranking job-related feeling on 0 to 6 scale; 0 = never had this feeling, 6 = every day had this feeling
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Baseline, 3 months, 6 months, 9 months, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quick Inventory of Depressive Symptomatology (QIDS-SR)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
|
Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) is a 16-item questionnaire that rates depression symptoms over the past seven days on an individual question scale of 0 to 3. Total scores range from 0 to 27 with higher scores indicating greater severity of depressive symptoms.
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Baseline, 3 months, 6 months, 9 months, 12 months
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Change in LASA Quality of Life Scale
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
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Linear Analogue Self-Assessment (LASA) 6-item questionnaire that assess feelings during the past week on an individual question scale of 0 to 10; 0 = as bad as it can be, 10 = as good as it can be.
Total scores range 6-60 with higher scores indicating better perception of quality of life.
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Baseline, 3 months, 6 months, 9 months, 12 months
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Sense of belonging
Time Frame: Baseline
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Measured using a 2- item self-reported questionnaire on sense of belonging to the nursing unit and hospital on an individual question scale of 0 to 4; 0=no opinion, 4=very strong.
Total scores range from 0 to 8 with higher score indicating a greater sense of belonging.
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Baseline
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Change in Food Intake Questionnaire
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
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Measured using a self-reported multifactor food intake 16-item questionnaire that assess how many times per day, week or month subjects ate each food on a scale of never, 1-3 times last month, 1-2 times per week, 3-4 times per week, 5-6 times per week, 1 time per day, 2 times per day, 3 times per day, 4 or more times per day
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Baseline, 3 months, 6 months, 9 months, 12 months
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Sleep quality
Time Frame: Every day over 12-month study period
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Measures by smartwatch that is worn daily by the subject reported in hours of sleep
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Every day over 12-month study period
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Daily heart rate
Time Frame: 12 months
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Measured by smartwatch that is worn daily by the subject reported in beats per minute
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12 months
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Daily physical activity
Time Frame: 12 months
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Measured by smartwatch that is worn daily by the subject reported in time spent in activity (minutes)
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12 months
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Daily step count
Time Frame: 12 months
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Measured by smartwatch that is worn daily by the subject reported in number of steps per day
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William Bobo, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
August 15, 2022
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
July 28, 2022
First Submitted That Met QC Criteria
July 28, 2022
First Posted (Actual)
August 1, 2022
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 19, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-000447
- R01NR020362-01 (U.S. NIH Grant/Contract)
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
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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