Clinical trial NCT05653700: Arena Labs - Improving Clinician Well Being
Official title: Atrium Health - Arena Labs Research Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Keywords: professional fulfillment
physiological resilience
high-stress environment
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Heart Rate Variability
timeFrame: Week 16
measure: Change in Resting Heart Rate
timeFrame: Week 16
measure: Change in Time Spent in Bed
timeFrame: Week 16
measure: Change in Sleep Quality
timeFrame: Week 16
measure: Change in Sleep Consistency
timeFrame: Week 16
measure: Change in Sleep Debt
timeFrame: Week 16
measure: Change in Amount of Burn Out (MBI) Malasch Burnout Inventory
timeFrame: Week 16
measure: Change in Self-reported Professional Fulfillment (PFI)
timeFrame: Week 16
measure: Change in Self-valuation Scores (Stanford Self-Vaulation)
timeFrame: Week 16
measure: Change in Personal Achievement (MBI)
timeFrame: week 16
measure: Change in Depersonalization (MBI)
timeFrame: week 16
measure: Change in Burnout Scores (PFI) - Professional Fulfillment Index
timeFrame: week 16
Secondary outcomes:
measure: Change in Self-reported Satisfaction of the Arena Strive Platform
timeFrame: Week 12
measure: Recommendation Score of the Arena Strive Platform
timeFrame: Week 12
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kevin Lobdell, MD
role: PRINCIPAL_INVESTIGATOR
References: