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OpenTrials
Completed

NCT Number: NCT05653700

Arena Labs - Improving Clinician Well Being

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.

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Key information

Conditions

Mental Health Disorder Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Control cohort

Other

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

Primary outcomes

  1. Change in Heart Rate Variability

    Time frame: 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

  2. Change in Resting Heart Rate

    Time frame: 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.

  3. Change in Time Spent in Bed

    Time frame: 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.

  4. Change in Sleep Quality

    Time frame: 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.

  5. Change in Sleep Consistency

    Time frame: 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.

  6. Change in Sleep Debt

    Time frame: 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.

  7. Change in Amount of Burn Out (MBI) Malasch Burnout Inventory

    Time frame: 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

  8. Change in Self-reported Professional Fulfillment (PFI)

    Time frame: 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

  9. Change in Self-valuation Scores (Stanford Self-Vaulation)

    Time frame: 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

  10. Change in Personal Achievement (MBI)

    Time frame: 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

  11. Change in Depersonalization (MBI)

    Time frame: 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

  12. Change in Burnout Scores (PFI) - Professional Fulfillment Index

    Time frame: 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

Secondary outcomes

  1. Change in Self-reported Satisfaction of the Arena Strive Platform

    Time frame: 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.

  2. Recommendation Score of the Arena Strive Platform

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Atrium Health - Arena Labs Research Protocol

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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