Arena Labs - Improving Clinician Well Being

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05653700
Collaborator
(none)
100
1
3
3.9
25.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Arena Strive
  • Device: WHOOP Sensor
  • Behavioral: Survey
N/A

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 14 weeks but will have optional access to the device for a total of 24 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
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).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)
Primary Purpose:
Supportive Care
Official Title:
Atrium Health - Arena Labs Research Protocol
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arena Strive

The experimental intervention employed in this study will be a 14-week, multi-phased approach involving a baseline data collection period (2 weeks), asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks).

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.

Other: Control Cohort

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

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

Other: Survey

survey at baseline and end of the study

Behavioral: Survey
survey at baseline and end of the study

Outcome Measures

Primary Outcome Measures

  1. Change in Heart Rate Variability [Week 14]

    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.

  2. Change in Resting Heart Rate [Week 14]

    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.

  3. Change in time spent in bed [Week 14]

    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 [Week 14]

    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 [Week 14]

    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 [Week 14]

    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 [Week 14]

    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

  8. Change in self-reported professional fulfillment [Week 14]

    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

  9. Change in self-valuation [Week 14]

    collected by means of an in-app survey at key benchmark moments throughout the intervention period

Secondary Outcome Measures

  1. Change in self-reported acceptance of the Arena Strive Platform [Week 14]

    collected by means of an in-app survey at key benchmark moments throughout the intervention period

  2. Change in self-reported satisfaction of the Arena Strive Platform [Week 14]

    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.

  3. percentage of feasibility of the Arena Strive Platform [Week 14]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanger Heart and Vascular Institute Charlotte North Carolina United States 28204

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Kevin Lobdell, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT05653700
Other Study ID Numbers:
  • IRB00090882
First Posted:
Dec 16, 2022
Last Update Posted:
Jan 31, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Wake Forest University Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2023