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To determine the efficacy of the asynchronous performance coaching platform, Arena Strive at changing measures of physiological resilience, professional fulfillment, burnout, and self-valuation in full time clinicians.
This study is a prospective randomized controlled longitudinal crossover design with a per protocol analysis integrating one sensor (WHOOP, inc Platform) and one educational intervention (Arena Strive Platform). The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep data, and will be worn by all participants in the experimental intervention. Participants will be asked to wear the biometric sensor for 12 weeks but will have optional access to the device for a total of 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arena Strive | Experimental | The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). |
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| Control Cohort | Other | Participants randomized into the control cohort - survey at baseline and end of the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arena Strive | Device | This second-generation platform provides frontline clinicians with a comprehensive journey to access the tools, training, and technology used by other high-pressure fields to increase performance and enhance resilience. The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. Values represent heart rate at specific intervals. The higher the HRV generally the better | Week 16 |
| Change in Resting Heart Rate | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. The lower heart rate at rest implies more efficient heart function and better cardiovascular fitness. | Week 16 |
| Change in Time Spent in Bed | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. | Week 16 |
| Change in Sleep Quality | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. | Week 16 |
| Change in Sleep Consistency |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-reported Satisfaction of the Arena Strive Platform | collected by means of an in-app survey at key benchmark moments throughout the intervention period - client satisfaction questionnaire 8 (CSQ-8) - Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Lobdell, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanger Heart and Vascular Institute | Charlotte | North Carolina | 28204 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices)
Beginning 9 months and ending 36 months following article publication
Investigators whose proposed use of the data has been approved by an independent review committee identified or this purpose
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Non Response is difference in Subject numbers
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| ID | Title | Description |
|---|---|---|
| FG000 | Arena Strive | The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). All participants will receive a Whoop device to capture biometric data. WHOOP Sensor: The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep data Arena Strive: This second-generation platform provides frontline clinicians with a comprehensive journey to access the tools, training, and technology used by other high-pressure fields to increase performance and enhance resilience. |
| FG001 | Control Cohort | Participants randomized into the control cohort - the intervention is the survey at baseline, mid-point, and end of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients were randomized into either control or intervention group (Arena Strive)
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| ID | Title | Description |
|---|---|---|
| BG000 | Arena Strive | The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). All participants will receive a Whoop device to capture biometric data. WHOOP Sensor: The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep data Arena Strive: This second-generation platform provides frontline clinicians with a comprehensive journey to access the tools, training, and technology used by other high-pressure fields to increase performance and enhance resilience. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Heart Rate Variability | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. Values represent heart rate at specific intervals. The higher the HRV generally the better | non response | Posted | Mean | 95% Confidence Interval | Milliseconds | Week 16 |
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through study completion, an average of 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arena Strive | The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). Arena Strive: This second-generation platform provides frontline clinicians with a comprehensive journey to access the tools, training, and technology used by other high-pressure fields to increase performance and enhance resilience. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Lobdell, MD | Wake Forest University Health Sciences | 704.355.1585 | kevin.lobdell@atriumhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2023 | Jul 25, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2023 | Nov 1, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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This study is a prospective randomized controlled longitudinal crossover design with a per protocol analysis integrating one sensor (WHOOP, inc Platform) and one educational intervention (Arena Strive Platform).
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| Control Cohort | Other | Participants randomized into the control cohort - survey at baseline and end of the study |
|
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. |
| Week 16 |
| Change in Sleep Debt | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. | Week 16 |
| Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Each item is measured on a scale of 0 to 6 and Total scores range from 0 (less/better burnout) - to 42 (more/worse burnout) - Total score of 17 or less: low level burnout total between 18 and 29 inclusive: moderate burnout total over 30: high-level of burnout | Week 16 |
| Change in Self-reported Professional Fulfillment (PFI) | collected by means of a survey link at key benchmark moments throughout the intervention period - Each item within PFI scored from 0 to 4 with higher scores being more favorable - scores range from 0 - 24 with higher scores denoting higher fulfillment | Week 16 |
| Change in Self-valuation Scores (Stanford Self-Vaulation) | collected by means of an in-app survey at key benchmark moments throughout the intervention period - Each item in the self-valuation scale included 4 items measured on a 5-point (0-4) Likert scale lower scores meaning more positivity -scores range from 0 - 16 with lower score denoting more positivity | Week 16 |
| Change in Personal Achievement (MBI) | "Each Item Measured on a scale of 0 to 6; Total 33 or less: high-level burnout - Total between 34 and 39 inclusive: moderate burnout - Total greater than 40: low-level burnout" Scores range from 0 - 48 with higher scores denoting less burnout | week 16 |
| Change in Depersonalization (MBI) | "Each item measured on a scale of 0 to 6; total score of 5 or less: low level burnout - total between 6 and 11 inclusive: moderate burnout - total over 12 and greater: high-level of burnout" - scores ranging from 0 - 42 with higher scores denoting more burnout | week 16 |
| Change in Burnout Scores (PFI) - Professional Fulfillment Index | Scores ranging 0 - 40 with higher scores denoting more exhaustion Likert scale ranging from "not at all" to "extremely" for work exhaustion and interpersonal disengagement item" - lower scores meaning less exhaustion | week 16 |
| Recommendation Score of the Arena Strive Platform |
Net Promoter Score with the question of likelihood to recommend - Net Promoter Score (NPS) is calculated by (promoters-detractors)/total respondents. The range is -100 to 100. The closer you are to 100 the more likely recommend. |
| Week 12 |
| BG001 | Control Cohort | Participants randomized into the control cohort - the intervention is the survey at baseline, mid-point, and end of the study |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Measurement was not collected | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Change in Resting Heart Rate | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. The lower heart rate at rest implies more efficient heart function and better cardiovascular fitness. | non response | Posted | Mean | 95% Confidence Interval | Beats per Minute | Week 16 |
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| Primary | Change in Time Spent in Bed | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. | Posted | Mean | 95% Confidence Interval | hours | Week 16 |
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| Primary | Change in Sleep Quality | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. | Data not collected | Posted | Week 16 |
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| Primary | Change in Sleep Consistency | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. | Data not collected | Posted | Week 16 |
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| Primary | Change in Sleep Debt | measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. | Data not collected | Posted | Week 16 |
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| Primary | Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Each item is measured on a scale of 0 to 6 and Total scores range from 0 (less/better burnout) - to 42 (more/worse burnout) - Total score of 17 or less: low level burnout total between 18 and 29 inclusive: moderate burnout total over 30: high-level of burnout | difference in Subject number due to Non-Responders | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
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| Primary | Change in Self-reported Professional Fulfillment (PFI) | collected by means of a survey link at key benchmark moments throughout the intervention period - Each item within PFI scored from 0 to 4 with higher scores being more favorable - scores range from 0 - 24 with higher scores denoting higher fulfillment | Survey non response accounts for difference in number of Subjects | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
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| Primary | Change in Self-valuation Scores (Stanford Self-Vaulation) | collected by means of an in-app survey at key benchmark moments throughout the intervention period - Each item in the self-valuation scale included 4 items measured on a 5-point (0-4) Likert scale lower scores meaning more positivity -scores range from 0 - 16 with lower score denoting more positivity | Survey non response accounts for difference in Subject number | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
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| Primary | Change in Personal Achievement (MBI) | "Each Item Measured on a scale of 0 to 6; Total 33 or less: high-level burnout - Total between 34 and 39 inclusive: moderate burnout - Total greater than 40: low-level burnout" Scores range from 0 - 48 with higher scores denoting less burnout | difference in Subject number due to non responders | Posted | Mean | Standard Deviation | score on a scale | week 16 |
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| Primary | Change in Depersonalization (MBI) | "Each item measured on a scale of 0 to 6; total score of 5 or less: low level burnout - total between 6 and 11 inclusive: moderate burnout - total over 12 and greater: high-level of burnout" - scores ranging from 0 - 42 with higher scores denoting more burnout | change in Subject number due to non responders | Posted | Mean | Standard Deviation | score on a scale | week 16 |
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| Primary | Change in Burnout Scores (PFI) - Professional Fulfillment Index | Scores ranging 0 - 40 with higher scores denoting more exhaustion Likert scale ranging from "not at all" to "extremely" for work exhaustion and interpersonal disengagement item" - lower scores meaning less exhaustion | change in Subject number due to non responders | Posted | Mean | Standard Error | score on a scale | week 16 |
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| Secondary | Change in Self-reported Satisfaction of the Arena Strive Platform | collected by means of an in-app survey at key benchmark moments throughout the intervention period - client satisfaction questionnaire 8 (CSQ-8) - Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Recommendation Score of the Arena Strive Platform | Net Promoter Score with the question of likelihood to recommend - Net Promoter Score (NPS) is calculated by (promoters-detractors)/total respondents. The range is -100 to 100. The closer you are to 100 the more likely recommend. | change is Subject number due to non-responses | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| 0 |
| 29 |
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| 29 |
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| 29 |
| EG001 | Control Cohort | Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study | 0 | 14 | 0 | 14 | 0 | 14 |
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