Mental Health Disorder
Conditions
Keywords
professional fulfillment, physiological resilience, high-stress environment
Brief summary
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.
Detailed description
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.
Interventions
DEVICEArena 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. 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).
OTHERControl Cohort
Participants randomized into the control cohort - survey at baseline and end of the study
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Employed full time by an Atrium Health affiliated entity * Age 18+ * Willing and able to give written informed consent for study participation * Healthcare workers working ≥ 36 hours of clinical duties/week * Willingness to wear WHOOP and keep it charged for the entire duration of study * Have a smart phone for pairing with WHOOP and the Arena Strive platform
Exclusion criteria
* Current diagnosis of a sleep-related breathing disorder including obstructive sleep apnea not being treated (with or without continuous positive airway pressure (CPAP) treatment) * Circadian rhythm sleep-wake disorders * Narcolepsy * Recurrent isolated sleep paralysis * Restless legs syndrome * Periodic Leg Movement Disorder * Comorbid nocturia or other conditions (benign prostatic hyperplasia) resulting in frequent need to get out of bed to use the bathroom during the night (≥3 times per night average) * Atrial Fibrillation * Chronic obstructive pulmonary disease (COPD) other than mild, pulmonary fibrosis or severe chronic lung disease * Sleep apnea or undergoing treatment for a sleep related illness * Lack of availability of iPhone or Android device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Burnout Scores (PFI) - Professional Fulfillment Index | week 16 | 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 Personal Achievement (MBI) | week 16 | 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 |
| Change in Depersonalization (MBI) | week 16 | 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 Heart Rate Variability | Week 16 | 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 |
| Change in Resting Heart Rate | Week 16 | 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. |
| Change in Time Spent in Bed | Week 16 | 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. |
| Change in Sleep Quality | Week 16 | 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. |
| Change in Sleep Consistency | Week 16 | 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. |
| Change in Sleep Debt | Week 16 | 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. |
| Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Week 16 | 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 |
| Change in Self-reported Professional Fulfillment (PFI) | Week 16 | 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 |
| Change in Self-valuation Scores (Stanford Self-Vaulation) | Week 16 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recommendation Score of the Arena Strive Platform | Week 12 | 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 in Self-reported Satisfaction of the Arena Strive Platform | Week 12 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Non Response is difference in Subject numbers
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Control Cohort Participants randomized into the control cohort - the intervention is the survey at baseline, mid-point, and end of the study | 14 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Non Responders | 9 | 0 |
Baseline characteristics
| Characteristic | Arena Strive | Control Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 14 Participants | 43 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 14 |
| other Total, other adverse events | 0 / 29 | 0 / 14 |
| serious Total, serious adverse events | 0 / 29 | 0 / 14 |
Outcome results
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
Time frame: Week 16
Population: difference in Subject number due to Non-Responders
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arena Strive | Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Week 6 | 20 score on a scale | Standard Deviation 9 |
| Arena Strive | Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Week 12 | 17 score on a scale | Standard Deviation 8 |
| Arena Strive | Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Week 16 | 16 score on a scale | Standard Deviation 10 |
| Control Cohort | Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Week 6 | 22 score on a scale | Standard Deviation 9 |
| Control Cohort | Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Week 12 | 15 score on a scale | Standard Deviation 10 |
| Control Cohort | Change in Amount of Burn Out (MBI) Malasch Burnout Inventory | Week 16 | 32 score on a scale | Standard Deviation 6 |
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
Time frame: week 16
Population: change in Subject number due to non responders
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arena Strive | Change in Burnout Scores (PFI) - Professional Fulfillment Index | Week 6 | 1.54 score on a scale | Standard Error 0.67 |
| Arena Strive | Change in Burnout Scores (PFI) - Professional Fulfillment Index | Week 12 | 1.23 score on a scale | Standard Error 0.63 |
| Arena Strive | Change in Burnout Scores (PFI) - Professional Fulfillment Index | Week 16 | 1.20 score on a scale | Standard Error 0.84 |
| Control Cohort | Change in Burnout Scores (PFI) - Professional Fulfillment Index | Week 6 | 1.56 score on a scale | Standard Error 0.55 |
| Control Cohort | Change in Burnout Scores (PFI) - Professional Fulfillment Index | Week 12 | 1.76 score on a scale | Standard Error 0.63 |
| Control Cohort | Change in Burnout Scores (PFI) - Professional Fulfillment Index | Week 16 | 1.76 score on a scale | Standard Error 0.7 |
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
Time frame: week 16
Population: change in Subject number due to non responders
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arena Strive | Change in Depersonalization (MBI) | Week 6 | 15 score on a scale | Standard Deviation 8 |
| Arena Strive | Change in Depersonalization (MBI) | week 12 | 11 score on a scale | Standard Deviation 7 |
| Arena Strive | Change in Depersonalization (MBI) | Week 16 | 11 score on a scale | Standard Deviation 8 |
| Control Cohort | Change in Depersonalization (MBI) | Week 6 | 12 score on a scale | Standard Deviation 8 |
| Control Cohort | Change in Depersonalization (MBI) | week 12 | 14 score on a scale | Standard Deviation 9 |
| Control Cohort | Change in Depersonalization (MBI) | Week 16 | 15 score on a scale | Standard Deviation 10 |
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
Time frame: Week 16
Population: non response
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arena Strive | Change in Heart Rate Variability | Mid (Week 12) | 47 Milliseconds |
| Arena Strive | Change in Heart Rate Variability | Beginning (Week 6) | 39 Milliseconds |
| Arena Strive | Change in Heart Rate Variability | End (Week 16) | 54 Milliseconds |
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
Time frame: week 16
Population: difference in Subject number due to non responders
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arena Strive | Change in Personal Achievement (MBI) | Week 6 | 38 score on a scale | Standard Deviation 8 |
| Arena Strive | Change in Personal Achievement (MBI) | Week 12 | 37 score on a scale | Standard Deviation 9 |
| Arena Strive | Change in Personal Achievement (MBI) | Week 16 | 37 score on a scale | Standard Deviation 9 |
| Control Cohort | Change in Personal Achievement (MBI) | Week 6 | 35 score on a scale | Standard Deviation 7 |
| Control Cohort | Change in Personal Achievement (MBI) | Week 12 | 34 score on a scale | Standard Deviation 7 |
| Control Cohort | Change in Personal Achievement (MBI) | Week 16 | 32 score on a scale | Standard Deviation 6 |
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.
Time frame: Week 16
Population: non response
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arena Strive | Change in Resting Heart Rate | Beginning (Week 6) | 63 Beats per Minute |
| Arena Strive | Change in Resting Heart Rate | Mid (Week 12) | 60 Beats per Minute |
| Arena Strive | Change in Resting Heart Rate | End (Week 16) | 57 Beats per Minute |
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
Time frame: Week 16
Population: Survey non response accounts for difference in number of Subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arena Strive | Change in Self-reported Professional Fulfillment (PFI) | Week 6 | 2.30 score on a scale | Standard Deviation 0.75 |
| Arena Strive | Change in Self-reported Professional Fulfillment (PFI) | Week 12 | 2.58 score on a scale | Standard Deviation 0.67 |
| Arena Strive | Change in Self-reported Professional Fulfillment (PFI) | Week 16 | 2.69 score on a scale | Standard Deviation 0.99 |
| Control Cohort | Change in Self-reported Professional Fulfillment (PFI) | Week 6 | 2.50 score on a scale | Standard Deviation 0.73 |
| Control Cohort | Change in Self-reported Professional Fulfillment (PFI) | Week 12 | 2.14 score on a scale | Standard Deviation 0.73 |
| Control Cohort | Change in Self-reported Professional Fulfillment (PFI) | Week 16 | 2.07 score on a scale | Standard Deviation 0.74 |
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
Time frame: Week 16
Population: Survey non response accounts for difference in Subject number
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arena Strive | Change in Self-valuation Scores (Stanford Self-Vaulation) | Week 6 | 5.93 score on a scale | Standard Deviation 2.42 |
| Arena Strive | Change in Self-valuation Scores (Stanford Self-Vaulation) | Week 12 | 7.19 score on a scale | Standard Deviation 2.84 |
| Arena Strive | Change in Self-valuation Scores (Stanford Self-Vaulation) | Week 16 | 7.60 score on a scale | Standard Deviation 2.68 |
| Control Cohort | Change in Self-valuation Scores (Stanford Self-Vaulation) | Week 6 | 6.57 score on a scale | Standard Deviation 2.59 |
| Control Cohort | Change in Self-valuation Scores (Stanford Self-Vaulation) | Week 12 | 6.85 score on a scale | Standard Deviation 2.7 |
| Control Cohort | Change in Self-valuation Scores (Stanford Self-Vaulation) | Week 16 | 7.64 score on a scale | Standard Deviation 2.87 |
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.
Time frame: Week 16
Population: Data not collected
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.
Time frame: Week 16
Population: Data not collected
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.
Time frame: Week 16
Population: Data not collected
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.
Time frame: Week 16
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arena Strive | Change in Time Spent in Bed | Mid (Week 12) | 7.60 hours |
| Arena Strive | Change in Time Spent in Bed | Beginning (Week 6) | 7.69 hours |
| Arena Strive | Change in Time Spent in Bed | End (Week 16) | 7.59 hours |
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arena Strive | Change in Self-reported Satisfaction of the Arena Strive Platform | 25.77 score on a scale | Standard Deviation 5.45 |
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.
Time frame: Week 12
Population: change is Subject number due to non-responses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arena Strive | Recommendation Score of the Arena Strive Platform | 7.45 score on a scale | Standard Deviation 2.61 |