Arena Labs - Improving Clinician Well Being

NCT05653700 | Completed Results FDA Device

• 1 other identifier: IRB00090882
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Disorder

Keywords

professional fulfillment; physiological resilience; high-stress environment

Outcome Measures

Primary Outcomes (12)

• 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

  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

Secondary Outcomes (2)

• Change in Self-reported Satisfaction of the Arena Strive Platform

  Week 12

• Recommendation Score of the Arena Strive Platform

  Week 12

Study Arms (2)

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).

Device: Arena Strive

Control Cohort

OTHER

Participants randomized into the control cohort - survey at baseline and end of the study

Other: Control Cohort

Interventions

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).

Arena Strive

Control Cohort OTHER

Participants randomized into the control cohort - survey at baseline and end of the study

Control Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

• Title: Kevin Lobdell, MD
• Organization: Wake Forest University Health Sciences

kevin.lobdell@atriumhealth.org

704.355.1585

Study Officials

• Kevin Lobdell, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: March 16, 2023
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified or this purpose

Locations

US (1)