Back to resultsArena Labs - Improving Clinician Well Being
Primary Purpose
Mental Health Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arena Strive
WHOOP Sensor
Survey
Sponsored by
About this trial
This is an interventional supportive care trial for Mental Health Disorder focused on measuring professional fulfillment, physiological resilience, high-stress environment
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
Sites / Locations
- Sanger Heart and Vascular Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Other
Arm Label
Arena Strive
Control Cohort
Survey
Arm Description
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).
Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
end of the study
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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
Change in self-valuation
collected by means of an in-app survey at key benchmark moments throughout the intervention period
Secondary Outcome Measures
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
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.
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
Full Information
NCT ID
NCT05653700
First Posted
December 8, 2022
Last Updated
August 31, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05653700
Brief Title
Arena Labs - Improving Clinician Well Being
Official Title
Atrium Health - Arena Labs Research Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder
Keywords
professional fulfillment, physiological resilience, high-stress environment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arena Strive
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Cohort
Arm Type
Other
Arm Description
Participants randomized into the control cohort - the intervention is the survey at baseline and end of the study
Arm Title
Survey
Arm Type
Other
Arm Description
end of the study
Intervention Type
Behavioral
Intervention Name(s)
Arena Strive
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
WHOOP Sensor
Intervention Description
The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep data
Intervention Type
Behavioral
Intervention Name(s)
Survey
Intervention Description
survey at baseline and end of the study
Primary Outcome Measure Information:
Title
Change in Heart Rate Variability
Description
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.
Time Frame
Week 12
Title
Change in Resting Heart Rate
Description
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.
Time Frame
Week 12
Title
Change in time spent in bed
Description
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.
Time Frame
Week 12
Title
Change in sleep quality
Description
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.
Time Frame
Week 12
Title
Change in sleep consistency
Description
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.
Time Frame
Week 12
Title
Change in sleep debt
Description
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.
Time Frame
Week 12
Title
Change in amount of burn out
Description
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
Time Frame
Week 12
Title
Change in self-reported professional fulfillment
Description
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
Time Frame
Week 12
Title
Change in self-valuation
Description
collected by means of an in-app survey at key benchmark moments throughout the intervention period
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in self-reported acceptance of the Arena Strive Platform
Description
collected by means of an in-app survey at key benchmark moments throughout the intervention period
Time Frame
Week 12
Title
Change in self-reported satisfaction of the Arena Strive Platform
Description
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.
Time Frame
Week 12
Title
percentage of feasibility of the Arena Strive Platform
Description
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
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Lobdell, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanger Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified or this purpose
Learn more about this trial
Arena Labs - Improving Clinician Well Being
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