ClinicalTrials.gg
CompletedNCT05148221Updated Nov 10, 2022

Mayo Clinic Family Medicine Resident Wellness Study

An interventional study of Questionnaires and Actigraph and activPAL devices in Sleep Patterns, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-10.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Sleep Patterns

Keywords

  • Acute and Chronic Cognitive Fatigue
  • Perceived burnout
  • Family Medicine Residency Program
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,264 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    A three-week tailored, virtual exercise intervention.

    A three-week tailored, virtual exercise intervention.

    Other: Questionnaires · Other: Actigraph and activPAL devices

Interventions

  • OtherQuestionnaires

    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.

  • OtherActigraph 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.

06

What researchers measure

Primary outcomes

  1. Work-related mental fatigue

    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.

    Time frame: up to 4 weeks

  2. Work-related burnout

    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.

    Time frame: up to 4 weeks

Secondary outcomes

  1. Sleep duration

    Number of hours of sleep per night measured using the activePAL inclinometer

    Time frame: up to 4 weeks

  2. Sleep disruptions

    Number of times shifting from lying to upright posture per night measured using the activePAL inclinometer

    Time frame: up to 4 weeks

  3. Horizontal shifts during sleep per night

    Number of horizontal shifts during sleep per night measured using the active PAL inclinometer

    Time frame: up to 4 weeks

Other outcomes

  1. Exercise duration

    Number of minutes per day of exercise measured by Actigraph wGT3Xbt accelerometer

    Time frame: up to 4 weeks

  2. Exercise Frequency

    Number of days per week of exercise measured by Actigraph wGT3Xbt accelerometer

    Time frame: up to 4 weeks

07

Study locations

1 site
  • Mayo Clinic Health System-Eau Claire
    Eau Claire, Wisconsin 54703, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05148221
Lead sponsor
Mayo Clinic
Responsible party
Terri Nordin (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Dec 8, 2021
Start date
Nov 1, 2021
Primary completion
Jul 15, 2022
Completion
Jul 15, 2022
Last update
Nov 10, 2022

Study contacts

Terri Nordin, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion