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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A three-week tailored, virtual exercise intervention.
Other: Questionnaires
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.
Other: Actigraph and activPAL devices
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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