- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07342673
Vital Coach: A Study of Resiliency in Medical Students
Vital Coach: A Study of Resiliency in Medical Students Using Wearable Technology and Personalized Wellness Coaching
Study Overview
Detailed Description
This gap represents both a health crisis and an educational opportunity. Burnout originating in medical school often persists into residency and practice, diminishing empathy and professionalism, and contributing to long-term attrition. Existing wellness offerings are largely reactive, relying on voluntary counseling or broad wellness sessions that fail to provide individualized insight into students' physiological readiness or stress recovery capacity. Moreover, schools lack objective, continuous data to pinpoint when students are physiologically stressed to tailor timely support.
Against this backdrop, this study proposes evaluating a structured performance coaching and biometric feedback approach in the context of scheduled academic stressors. Arena Strive is a digital coaching platform that integrates a virtual human performance coach, wearable-derived biometric data, and a focused skills curriculum adapted from other high-stress domains and tailored to frontline healthcare workers. This novel intervention has proven effective in significantly reducing burnout and enhancing professional fulfillment and self-valuation in a large health-system through an 8-week intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dermot Phelan, MD, PhD
- Phone Number: 704 373 0212
- Email: Dermot.Phelan@Advocatehealth.org
Study Contact Backup
- Name: Dana Amaro
- Phone Number: 704-355-4692
- Email: dana.amaro@advocatehealth.org
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
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Contact:
- Dermot Phelan, MD, PhD
- Phone Number: 704-373-0212
- Email: Dermot.Phelan@Advocatehealth.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- active first year Wake Forest School of Medicine medical students
- have an Android or iOS smart phone
- are willing to download the Arena Strive application
Exclusion Criteria:
- under the age of 18; or over the age of 60
- pregnant at enrollment or during course of study
- any self-reported cardiac conditions that may impact heart rate and heart rate variability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Arena Strive
digital coaching platform, which integrates asynchronous coaching, two virtual coaching sessions with a high-performance medicine coach, physiological data from wearable sensors, and a focused curriculum of performance tools tailored to frontline healthcare workers.
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integrates asynchronous coaching, two virtual coaching sessions with a high-performance medicine coach, physiological data from wearable sensors, and a focused curriculum of performance tools tailored to frontline healthcare workers.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heart Rate Variability
Time Frame: Weekly through Week 13
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Mean daily nocturnal Heart Rate Variability (HRV): Higher = Better
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Weekly through Week 13
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Resting Heart Rate (Beats per Minute)
Time Frame: Weekly through Week 13
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daily nocturnal Resting Heart Rate (RHR): Lower = Better
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Weekly through Week 13
|
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Sleep Duration (minutes)
Time Frame: Weekly through Week 13
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Mean nightly sleep: Higher = Better
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Weekly through Week 13
|
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Sleep Consistency (minutes)
Time Frame: Weekly through Week 13
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SD of mid-sleep time: Lower = Better
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Weekly through Week 13
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Perceived Stress (Perceived Stress Scale PSS-4) Scores
Time Frame: Weekly through Week 13
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To score the Perceived Stress Scale 4 (PSS-4), first, reverse the scores for questions 2 and 3 (0 becomes 4, 1 becomes 3, 2 stays 2, 3 becomes 1, and 4 becomes 0).
Then, add up the scores for all four questions.
The total score will range from 0 to 16, with higher scores indicating greater perceived stress.
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Weekly through Week 13
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Change in Burnout (Maslach Burnout Inventory MBI-GSS) Scores
Time Frame: Week 13
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MBI-GSS scoring involves summing responses for each of its three subscales: emotional exhaustion, cynicism, and professional efficacy, which are rated on a 7-point frequency scale from 0 (never) to 6 (daily).
To determine burnout, high scores on exhaustion and cynicism indicate higher burnout, while low scores on professional efficacy suggest greater burnout.
These subscale scores are then interpreted separately to understand the level of burnout for each dimension.
Each item is rated on a frequency scale (e.g., 0 to 6), and higher or lower scores on each subscale indicate different levels of burnout.
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Week 13
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Exam Performance checklist
Time Frame: Week 13
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Exam performance for the three exams during the study period is self-reported by participants via a typeform in the application at the study conclusion.
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Week 13
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Weekly mean nocturnal HRV (RMSSD, ms) measured via wearable device during intervention and compared to other phases.
Time Frame: Weekly through Week 13
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HRV will be assessed using the root mean square of successive differences (RMSSD, ms) to provide a daily individual score derived from nightly photoplethysmography (PPG) wearable-recorded data. All primary endpoints are computed at the individual level and compared by week, using week-level means (averaged from the individual daily scores). Heart Rate Variability (HRV) [RMSSD, ms] Individual Test= Like earlier mentioned tests these will include week-to-week differences for the weeks during the phase (Baseline Week, Study Week, Exam Week, Recovery Week) (ex. HRV_Recovery (during) - HRV_Exam (during) and comparisons with pre/post intervention phases (ex. HRV_Recovery (during) - HRV_Recovery (pre-intervention)). Group Test= A linear mixed model for HRV and PSS-4 with fixed effects for Week, Phase (0=pre, 1=post, 2=during) and a Week x Phase interaction, plus a random intercept for participant. Sensitivity Analyses= Paired t-tests (Wilcoxon as nonparametric alternative). |
Weekly through Week 13
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Weekly mean nocturnal RHR (bpm) measured via wearable device during intervention and compared to other phases.
Time Frame: Weekly through Week 13
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Daily mean RHR (bpm) will be derived from nightly PPG wearable-recorded data. All primary endpoints are computed at the individual level and compared by week using week-level means (averaged from the individual daily scores). Resting Heart Rate (RHR) [bpm] Individual Test= Like earlier mentioned tests these will include week-to-week differences for the weeks during the phase (Baseline Week, Study Week, Exam Week, Recovery Week) (ex. RHR_Recovery (during) - RHR_Exam (during) and comparisons with pre/post intervention phases (ex. RHR_Recovery (during) - RHR_Recovery (pre-intervention)). Group Test= A linear mixed model for RHR and PSS-4 with fixed effects for Week, Phase (0=pre, 1=post, 2=during) and a Week x Phase interaction, plus a random intercept for participant. Sensitivity Analyses= Paired t-tests (Wilcoxon as nonparametric alternative). |
Weekly through Week 13
|
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Weekly mean Sleep Duration (min) measured via wearable device during intervention and compared to other phases.
Time Frame: Weekly through Week 13
|
Daily Sleep Duration (min) will be derived from nightly PPG wearable-recorded data. All primary endpoints are computed at the individual level and compared by week using week-level means (averaged from the individual daily scores). Sleep Duration [min] Individual Test= Like earlier mentioned tests these will include week-to-week differences for the weeks during the phase (Baseline Week, Study Week, Exam Week, Recovery Week) (ex. SleepDuration_Recovery (during) - Sleep Duration_Exam (during) and comparisons with pre/post intervention phases (ex. SleepDuration_Recovery (during) - SleepDuration_Recovery (pre-intervention)). Group Test= A linear mixed model for Sleep Duration and PSS-4 with fixed effects for Week, Phase (0=pre, 1=post, 2=during) and a Week x Phase interaction, plus a random intercept for participant. Sensitivity Analyses= Paired t-tests (Wilcoxon as nonparametric alternative). |
Weekly through Week 13
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Weekly Sleep Consistency (SD of mid-sleep time, min) measured via wearable device during intervention and compared to other phases.
Time Frame: Weekly through Week 13
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Sleep Consistency will be measured as the standard deviation of nightly mid-sleep time derived from wearable-recorded sleep onset and offset times over each 7-day period, aggregated weekly at the individual level and compared across pre-intervention, intervention, and post-intervention phases. Sleep Consistency Individual Test= Like earlier mentioned tests these will include week-to-week differences for the weeks during the phase (Baseline Week, Study Week, Exam Week, Recovery Week) (ex. SleepConsistency_Recovery (during) - SleepConsistency_Exam (during) and comparisons with pre/post intervention phases (ex. SleepConsistency_Recovery (during) - SleepConsitency_Recovery (pre-intervention)). Group Test= A linear mixed model for Sleep Consistency and PSS-4 with fixed effects for Week, Phase (0=pre, 1=post, 2=during) and a Week x Phase interaction, plus a random intercept for participant. Sensitivity Analyses= Paired t-tests (Wilcoxon as nonparametric alternative). |
Weekly through Week 13
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Heterogeneity of effects (sensitivity only)
Time Frame: Weekly through Week 13
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Moderation by demographics (age, race, gender) on primary outcomes.
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Weekly through Week 13
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Collaborators and Investigators
Investigators
- Principal Investigator: Dermot Phelan, MD, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00140462
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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