Trial Outcomes & Findings for Arena Labs - Improving Clinician Well Being (NCT NCT05653700)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

Week 16

Results posted on

2024-12-04

Participant Flow

Non Response is difference in Subject numbers

Participant milestones

Participant milestones
Measure	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.	Control Cohort Participants randomized into the control cohort - the intervention is the survey at baseline, mid-point, and end of the study
Overall Study STARTED	29	14
Overall Study COMPLETED	20	14
Overall Study NOT COMPLETED	9	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Control Cohort Participants randomized into the control cohort - the intervention is the survey at baseline, mid-point, and end of the study
Overall Study Non Responders	9	0

Baseline Characteristics

Measurement was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arena Strive n=29 Participants 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.	Control Cohort n=14 Participants Participants randomized into the control cohort - the intervention is the survey at baseline, mid-point, and end of the study	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=29 Participants	0 Participants n=14 Participants	0 Participants n=43 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=29 Participants	14 Participants n=14 Participants	43 Participants n=43 Participants
Age, Categorical >=65 years	0 Participants n=29 Participants	0 Participants n=14 Participants	0 Participants n=43 Participants
Sex: Female, Male Female	0 Participants Measurement was not collected	0 Participants Measurement was not collected	0 Participants Measurement was not collected
Sex: Female, Male Male	0 Participants Measurement was not collected	0 Participants Measurement was not collected	0 Participants Measurement was not collected
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Week 16

Population: non response

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

Outcome measures

Outcome measures
Measure	Arena Strive n=29 Participants 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.	Control Cohort Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Heart Rate Variability Beginning (Week 6)	39 Milliseconds Interval 27.0 to 56.0	—
Change in Heart Rate Variability Mid (Week 12)	47 Milliseconds Interval 32.0 to 65.0	—
Change in Heart Rate Variability End (Week 16)	54 Milliseconds Interval 35.0 to 82.0	—

PRIMARY outcome

Timeframe: Week 16

Population: non response

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.

Outcome measures

Outcome measures
Measure	Arena Strive n=29 Participants 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.	Control Cohort Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Resting Heart Rate Beginning (Week 6)	63 Beats per Minute Interval 57.0 to 68.0	—
Change in Resting Heart Rate Mid (Week 12)	60 Beats per Minute Interval 55.0 to 65.0	—
Change in Resting Heart Rate End (Week 16)	57 Beats per Minute Interval 51.0 to 61.0	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arena Strive n=29 Participants 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.	Control Cohort Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Time Spent in Bed Beginning (Week 6)	7.69 hours Interval 6.83 to 8.67	—
Change in Time Spent in Bed Mid (Week 12)	7.60 hours Interval 6.6 to 8.55	—
Change in Time Spent in Bed End (Week 16)	7.59 hours Interval 6.56 to 9.05	—

PRIMARY outcome

Timeframe: Week 16

Population: Data not collected

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 16

Population: Data not collected

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 16

Population: Data not collected

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 16

Population: difference in Subject number due to Non-Responders

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

Outcome measures

Outcome measures
Measure	Arena Strive n=29 Participants 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.	Control Cohort n=14 Participants Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Amount of Burn Out (MBI) Malasch Burnout Inventory Week 16	16 score on a scale Standard Deviation 10	32 score on a scale Standard Deviation 6
Change in Amount of Burn Out (MBI) Malasch Burnout Inventory Week 6	20 score on a scale Standard Deviation 9	22 score on a scale Standard Deviation 9
Change in Amount of Burn Out (MBI) Malasch Burnout Inventory Week 12	17 score on a scale Standard Deviation 8	15 score on a scale Standard Deviation 10

PRIMARY outcome

Timeframe: Week 16

Population: Survey non response accounts for difference in number of Subjects

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

Outcome measures

Outcome measures
Measure	Arena Strive n=29 Participants 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.	Control Cohort n=14 Participants Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Self-reported Professional Fulfillment (PFI) Week 6	2.30 score on a scale Standard Deviation 0.75	2.50 score on a scale Standard Deviation 0.73
Change in Self-reported Professional Fulfillment (PFI) Week 12	2.58 score on a scale Standard Deviation 0.67	2.14 score on a scale Standard Deviation 0.73
Change in Self-reported Professional Fulfillment (PFI) Week 16	2.69 score on a scale Standard Deviation 0.99	2.07 score on a scale Standard Deviation 0.74

PRIMARY outcome

Timeframe: Week 16

Population: Survey non response accounts for difference in Subject number

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

Outcome measures

Outcome measures
Measure	Arena Strive n=29 Participants 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.	Control Cohort n=14 Participants Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Self-valuation Scores (Stanford Self-Vaulation) Week 6	5.93 score on a scale Standard Deviation 2.42	6.57 score on a scale Standard Deviation 2.59
Change in Self-valuation Scores (Stanford Self-Vaulation) Week 12	7.19 score on a scale Standard Deviation 2.84	6.85 score on a scale Standard Deviation 2.70
Change in Self-valuation Scores (Stanford Self-Vaulation) Week 16	7.60 score on a scale Standard Deviation 2.68	7.64 score on a scale Standard Deviation 2.87

PRIMARY outcome

Timeframe: week 16

Population: difference in Subject number due to non responders

"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

Outcome measures

Outcome measures
Measure	Arena Strive n=28 Participants 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.	Control Cohort n=14 Participants Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Personal Achievement (MBI) Week 6	38 score on a scale Standard Deviation 8	35 score on a scale Standard Deviation 7
Change in Personal Achievement (MBI) Week 12	37 score on a scale Standard Deviation 9	34 score on a scale Standard Deviation 7
Change in Personal Achievement (MBI) Week 16	37 score on a scale Standard Deviation 9	32 score on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: week 16

Population: change in Subject number due to non responders

"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

Outcome measures

Outcome measures
Measure	Arena Strive n=28 Participants 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.	Control Cohort n=14 Participants Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Depersonalization (MBI) Week 6	15 score on a scale Standard Deviation 8	12 score on a scale Standard Deviation 8
Change in Depersonalization (MBI) week 12	11 score on a scale Standard Deviation 7	14 score on a scale Standard Deviation 9
Change in Depersonalization (MBI) Week 16	11 score on a scale Standard Deviation 8	15 score on a scale Standard Deviation 10

PRIMARY outcome

Timeframe: week 16

Population: change in Subject number due to non responders

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

Outcome measures

Outcome measures
Measure	Arena Strive n=29 Participants 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.	Control Cohort n=14 Participants Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Burnout Scores (PFI) - Professional Fulfillment Index Week 6	1.54 score on a scale Standard Error 0.67	1.56 score on a scale Standard Error 0.55
Change in Burnout Scores (PFI) - Professional Fulfillment Index Week 12	1.23 score on a scale Standard Error 0.63	1.76 score on a scale Standard Error 0.63
Change in Burnout Scores (PFI) - Professional Fulfillment Index Week 16	1.20 score on a scale Standard Error 0.84	1.76 score on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arena Strive n=22 Participants 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.	Control Cohort Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Change in Self-reported Satisfaction of the Arena Strive Platform	25.77 score on a scale Standard Deviation 5.45	—

SECONDARY outcome

Timeframe: Week 12

Population: change is Subject number due to non-responses

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.

Outcome measures

Outcome measures
Measure	Arena Strive n=22 Participants 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.	Control Cohort Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Recommendation Score of the Arena Strive Platform	7.45 score on a scale Standard Deviation 2.61	—

Adverse Events

Arena Strive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin Lobdell, MD

Wake Forest University Health Sciences

Phone: 704.355.1585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place