- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05148221
Mayo Clinic Family Medicine Resident Wellness Study
November 8, 2022 updated by: Terri Nordin, Mayo Clinic
Mayo Clinic Family Medicine Resident Wellness Study: Feasibility of a Tailored Virtual Exercise Program and Its Impacts on Sleep Patterns and Subjective Mental Fatigue Among Family Medicine Residents: A Step Towards Prevention of Burnout in Early Career Physicians
The objectives of this study are to better understand the association between sleep characteristics (sleep disruptions and deprivations) during overnight shifts and mental fatigue among medical residents, and to explore the feasibility of a virtual, tailored exercise program on sleep characteristics, subjective mental fatigue, and burnout level among residents in family medicine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of the proposed study is two-fold: 1) to better understand the association between sleep characteristics (sleep disruptions and deprivations) during overnight shifts and mental fatigue among medical residents; and 2) to explore the feasibility of a three-week tailored, virtual exercise program on sleep characteristics, subjective mental fatigue, and burnout level among residents in family medicine.
It is hypothesized that: 1) the greater the number of average sleep disruptions, and the greater the sleep deprivation, the greater the acute mental fatigue during overnight shifts reported by the family medicine residents; 2) the number of average sleep disruptions and the magnitude of sleep deprivation are greater during overnight shifts than non-overnight shifts among family medicine residents; and 3) a three-week tailored virtual exercise program will significantly increase the amount of physical activity throughout the day and reduce the levels of mental fatigue and perceived burnout during overnight shifts.
Study Type
Interventional
Enrollment (Actual)
13
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 Locations
-
-
Wisconsin
-
Eau Claire, Wisconsin, United States, 54703
- Mayo Clinic Health System-Eau Claire
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• A Family Medicine Resident at the Mayo Clinic Health System of Eau Claire in either the PGY-1 Year, PGY-2 Year, or PGY-2 Year (5 residents from each year).
Exclusion Criteria:
- Participant is not able to wear the devices for the assigned timeframe.
- Any condition the investigator considers will prevent compliance with study instructions.
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A three-week tailored, virtual exercise intervention.
|
Once each participant signs an informed consent form upon agreeing to participate in the study, they will be asked to complete a simple demographic questionnaire including year in program, work schedule, self-reported height and weight, age, and sex.
They will also be interviewed by a faculty of university of Wisconsin-Eau Claire (UWEC) regarding their current and past exercise habits, exercise preferences, and perceived exercise barriers.
Two questionnaires listed above (Occupational Fatigue Exhaustion Recovery (OFER 15) and Maslach Burnout Inventory (MBI)) will also be completed by each participant on Qualtrics online platform.
Actigraph and activPAL devices will be set up based on the demographic information and will be provided to each participant to wear for 7 consecutive days during all waking hours and sleep, except when bathing or swimming.
If the first 7-day monitoring period was an overnight inpatient week, the second 7-day monitoring period will be scheduled during a non-overnight week.
A day before the first day of the second monitoring period, a new set of Actigraph and activPAL devices will be delivered to each participant.
Once the second monitoring period ends, devices will be retrieved from each participant, and data will be downloaded from devices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work-related mental fatigue
Time Frame: up to 4 weeks
|
Subjective work-related mental fatigue will be measured using the OFER 15 which has 15 items on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree).
The three subscales of OFER 15 include: chronic fatigue (items 1-5), acute fatigue (items 6-10), and inter-shift recovery (items 11-15) experienced in the past few months.
Scores for each subscale range from 0-100.
Higher scores indicate acute and chronic fatigue and greater inter-shift recovery.
|
up to 4 weeks
|
Work-related burnout
Time Frame: up to 4 weeks
|
Levels of burnout will be assessed using the Maslach Burnout Inventory (MBI) which has 22 items on a 7-point Likert scale of 0 (never) to 6 (every day), consisting of three subscales of burnout: emotional exhaustion, depersonalization, and personal accomplishment.
Low personal accomplishment scores, high emotional exhaustion scores, and high depersonalization scores suggest increased levels of burnout.
|
up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep duration
Time Frame: up to 4 weeks
|
Number of hours of sleep per night measured using the activePAL inclinometer
|
up to 4 weeks
|
Sleep disruptions
Time Frame: up to 4 weeks
|
Number of times shifting from lying to upright posture per night measured using the activePAL inclinometer
|
up to 4 weeks
|
Horizontal shifts during sleep per night
Time Frame: up to 4 weeks
|
Number of horizontal shifts during sleep per night measured using the active PAL inclinometer
|
up to 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise duration
Time Frame: up to 4 weeks
|
Number of minutes per day of exercise measured by Actigraph wGT3Xbt accelerometer
|
up to 4 weeks
|
Exercise Frequency
Time Frame: up to 4 weeks
|
Number of days per week of exercise measured by Actigraph wGT3Xbt accelerometer
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Terri Nordin, 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)
November 1, 2021
Primary Completion (Actual)
July 15, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
October 18, 2021
First Submitted That Met QC Criteria
November 24, 2021
First Posted (Actual)
December 8, 2021
Study Record Updates
Last Update Posted (Actual)
November 10, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 21-007624
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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