Sleep PatternsNCT05148221
Mayo Clinic Family Medicine Resident Wellness Study
A study testing Questionnaires and Actigraph and activPAL devices in people with Sleep Patterns, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Patterns
- What is being tested?
- Questionnaires and Actigraph and activPAL devices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Participant is not able to wear the devices for the assigned timeframe.
- Any condition the investigator considers will prevent compliance with study instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, 54703
About this study
Official title: 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.
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.
- Conditions
- Sleep Patterns
- Being tested
- Questionnaires, Actigraph and activPAL devices
- Keywords
- Acute and Chronic Cognitive Fatigue, Perceived burnout, Family Medicine Residency Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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 devicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A three-week tailored, virtual exercise intervention. | Experimental | A three-week tailored, virtual exercise intervention. Receives: Other: Questionnaires; Other: Actigraph and activPAL devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
Secondary outcomes (3)
Sleep duration
Number of hours of sleep per night measured using the activePAL inclinometer
Measured: up to 4 weeks
Sleep disruptions
Number of times shifting from lying to upright posture per night measured using the activePAL inclinometer
Measured: up to 4 weeks
Horizontal shifts during sleep per night
Number of horizontal shifts during sleep per night measured using the active PAL inclinometer
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Nov 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep PatternsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terri Nordin, Mayo Clinic
- Investigators
- Terri Nordin, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148221
- Sponsor's protocol ID
- 21-007624
- Status last verified
- Nov 2022
- First submitted
- 18 Oct 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05148221
- Acronym / sponsor ID
- 21-007624
- Conditions
- Sleep Patterns
- Keywords
- Acute and Chronic Cognitive Fatigue, Perceived burnout, Family Medicine Residency Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A three-week tailored, virtual exercise intervention. | Experimental | Other: Questionnaires, Other: Actigraph and activPAL devicesA three-week tailored, virtual exercise intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- Participant is not able to wear the devices for the assigned timeframe.
- Any condition the investigator considers will prevent compliance with study instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesOnce 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 | A three-week tailored, virtual exercise intervention. |
| Actigraph and activPAL devicesActigraph 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. | Other | A three-week tailored, virtual exercise intervention. |
Primary outcome
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.
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.
3 secondary outcomes
Sleep duration
Time frame: up to 4 weeks
Sleep disruptions
Time frame: up to 4 weeks
Horizontal shifts during sleep per night
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terri Nordin, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires and Actigraph and activPAL devices in people with Sleep Patterns, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work-related mental fatigue (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.