Arena Labs - Improving Clinician Well Being

Mental Health Disorder Clinical Trial

Official title:

Atrium Health - Arena Labs Research Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05653700
• Other study ID #: IRB00090882
• Status: Completed
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: August 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder

Intervention

Behavioral:
• 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.

Device:
• WHOOP Sensor
The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep data

Behavioral:
• Survey
survey at baseline and end of the study

Locations

Country	Name	City	State
United States	Sanger Heart and Vascular Institute	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 12
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.	Week 12
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.	Week 12
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.	Week 12
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.	Week 12
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.	Week 12
Primary	Change in amount of burn out	collected by means of a paper survey at key benchmark moments throughout the intervention period - scored from 0 to 16 with higher scores being more favorable	Week 12
Primary	Change in self-reported professional fulfillment	collected by means of a paper survey at key benchmark moments throughout the intervention period - scored from 0 to 5 with higher scores being more favorable	Week 12
Primary	Change in self-valuation	collected by means of an in-app survey at key benchmark moments throughout the intervention period	Week 12
Secondary	Change in self-reported acceptance of the Arena Strive Platform	collected by means of an in-app survey at key benchmark moments throughout the intervention period	Week 12
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.	Week 12
Secondary	percentage of feasibility of the Arena Strive Platform	collected by means of an in-app survey at key benchmark moments throughout the intervention period - Net Promoter Score with the question of likelihood to recommend	Week 12