Burnout, ProfessionalNCT05033379
Healthcare Worker Resilience as Measured by Physiologic Feedback
A study testing Resilience coaching in people with Burnout, Professional, run by Stanford University at 1 site in United States.
Trial summary
Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Resilience coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2023to 30 Jun 2024
- 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
- Study participants will include full time clinically active healthcare workers
Who cannot join
- Exclusion criteria will be anyone who is not a full-time clinical healthcare worker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Circadian Alignment, Autonomic Control, and Physiologic Feedback on Measures of Resilience: A Multicenter Randomized Controlled Trial
Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors including mindfulness training and diet can maximize recovery and performance. The goal of this study is to quantify the impact if modifiable daily behaviors including sleep, nutrition, in order to understand the factors that contribute to high level performance, burnout, and physician wellbeing in surgical trainees and attendings.
Read the detailed description
Informed consent will be obtained prior to participation in the research study. A member of the research team will provide the participant with the consent form and allow them adequate time to read and ask questions prior to giving consent. If consent is not obtained, the participant will not be allowed to participate in the research study.
Participants will be asked to wear a biometric sensor for six months. The biometric sensor (The WHOOP strap) collects heart rate, heart rate variability, activity, and sleep metrics. Half of the participants will complete coaching to improve resilience with Arena Strive and half will be a control group instructed that sleep is important. In the latter 3 months of the study, the control group will have the opportunity to wear a continuous glucose monitor. At the completion of the study period all participants will have access to Arena strive coaching.
Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, glucose levels using continuous glucose monitoring, exercise and mindfulness.
- Conditions
- Burnout, Professional
- Being tested
- Control, Resilience coaching
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Importance of sleep
Resilience coachingBehavioural
Arena Strive
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Experimental | Instruction about importance of sleep. Receives: Behavioral: Control |
| Coaching | Experimental | Undergo resilience coaching Receives: Behavioral: Resilience coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery
Using WHOOP algorithm, recovery will be quantified using heart rate variability and sleep, and serve as a measure of stress and resilience
Measured: 6 months
Secondary outcomes (2)
Burnout
The Physician Fulfillment Index is a quantitative measure of physician burnout and will be administered at baseline and at the end of the study.
Measured: 6 months
Health Habits
Changes in sleep metrics (duration of sleep, quality of sleep, and pre-sleep habits including light exposure and eating habits before sleep) and diet habits (evaluated by dietary pattern, ie, traditional Westernized, healthy Mediterranean, unhealthy - animal protein and alcohol, at beginning and end of the study) will be assessed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start29 Aug 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Cindy Kin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033379
- Sponsor's protocol ID
- 61917
- Status last verified
- Mar 2024
- First submitted
- 17 Aug 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Circadian Alignment, Autonomic Control, and Physiologic Feedback on Measures of Resilience: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05033379
- Acronym / sponsor ID
- 61917
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 Sep 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.
Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors including mindfulness training and diet can maximize recovery and performance. The goal of this study is to quantify the impact if modifiable daily behaviors including sleep, nutrition, in order to understand the factors that contribute to high level performance, burnout, and physician wellbeing in surgical trainees and attendings.
Detailed description
Informed consent will be obtained prior to participation in the research study. A member of the research team will provide the participant with the consent form and allow them adequate time to read and ask questions prior to giving consent. If consent is not obtained, the participant will not be allowed to participate in the research study.
Participants will be asked to wear a biometric sensor for six months. The biometric sensor (The WHOOP strap) collects heart rate, heart rate variability, activity, and sleep metrics. Half of the participants will complete coaching to improve resilience with Arena Strive and half will be a control group instructed that sleep is important. In the latter 3 months of the study, the control group will have the opportunity to wear a continuous glucose monitor. At the completion of the study period all participants will have access to Arena strive coaching.
Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, glucose levels using continuous glucose monitoring, exercise and mindfulness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Experimental | Behavioral: ControlInstruction about importance of sleep. |
| Coaching | Experimental | Behavioral: Resilience coachingUndergo resilience coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study participants will include full time clinically active healthcare workers
Key exclusion criteria (1 listed)
- Exclusion criteria will be anyone who is not a full-time clinical healthcare worker
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 |
|---|---|---|
| ControlImportance of sleep | Behavioural | Control Arm |
| Resilience coachingArena Strive | Behavioural | Coaching |
Primary outcome
Recovery
Time frame: 6 months
Using WHOOP algorithm, recovery will be quantified using heart rate variability and sleep, and serve as a measure of stress and resilience
2 secondary outcomes
Burnout
Time frame: 6 months
Health Habits
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience coaching in people with Burnout, Professional, run by Stanford University 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 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. 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?
Results are not available in the source record.
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?
Recovery (time frame: 6 months). 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 28 Mar 2024.