Arena Labs - Improving Clinician Well Being

NCT ID: NCT05653700

Last Updated: 2024-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-16

Study Completion Date

2023-07-25

Brief Summary

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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

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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.

Conditions

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Mental Health Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arena Strive

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).

Group Type EXPERIMENTAL

Arena Strive

Intervention Type 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

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

Group Type OTHER

Control Cohort

Intervention Type OTHER

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

Interventions

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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. 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).

Intervention Type DEVICE

Control Cohort

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Lobdell, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00090882

Identifier Type: -

Identifier Source: org_study_id