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Comprehensive and Continuous Status Measurement of Pre- and Post-Deployment Warfighters With Mobile Application

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ClinicalTrials.gov Identifier: NCT04672811
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Leslie Saxon, MD, University of Southern California

Tracking Information
First Submitted Date  ICMJE December 11, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date January 11, 2021
Estimated Study Start Date  ICMJE January 18, 2021
Estimated Primary Completion Date January 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
Warfighter Status [ Time Frame: 6 months ]
Rate of self-reported incidents characteristic of overall mental or physical degradation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
Warfighter Self-Knowledge [ Time Frame: 6 months ]
Post-study survey of self-reported improvement of warfighter self-knowledge and personal awareness on best methods to monitor and maximize mental and physical performance with biofeedback and summary reports
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comprehensive and Continuous Status Measurement of Pre- and Post-Deployment Warfighters With Mobile Application
Official Title  ICMJE Digital cORA (Comprehensive Operator Readiness Assessment): Comprehensive and Continuous Mental and Physical Status Measurement of Pre- and Post-Deployment Warfighters With Mobile Application
Brief Summary In this study, we aim to continuously and comprehensively measure the mental and physical status of US Military Special Operation Forces (SOF) through a confidential and cybersecure research mobile application (app) over a six-month period. In conjunction with data collected via the mobile app, wearable sensors, such as the Apple Watch, will be used to continuously collect physiologic (e.g. heart rate) and other data (e.g. activity, sleep). Additionally, the app will have the capability of delivering helpful features, such as information and activities to ideally support study subjects, mitigate degradation, and optimize performance. The overall objective of the proposal is to investigate whether the app can contribute to reducing overall warfighter degradation and if degradation can be predicted from daily continuous measures of physical and mental behavior.
Detailed Description Special Operations Forces (SOF) warfighters experience tremendous physical and mental strain and degradation after returning from deployment and during training prior to deployment. This degradation has been loosely linked to behavior termed "red-line" events, such as alcohol abuse, suicide, and divorce, however there is a lack of comprehensive evaluation directly linking "red-line" behavior to physical and mental degradation. To address this issue, a program called Comprehensive Operator Readiness Assessment (cORA) was implemented for 3rd SFG(A) Green Beret warfighters at Fort Bragg as a holistic one- day physical and mental assessment to help identify and mitigate performance-degrading factors. However, due to the in-person nature of the cORA assessment, the scalability of the program is limited. Additionally, the current program only captures a snapshot of physical and mental status as all the data is collected on one day. In this study, we aim to perform a research study where we scale the cORA program by transforming it into a confidential, cybersecure research mobile application (app), called Digital cORA, that will digitize the existing measures of the program, as well as collect continuous measures of warfighter physical, neurocognitive (e.g. spatial memory, working memory), psychological, and lifestyle factors over a six-month period. In conjunction with data collected via the mobile app, wearable sensors will be used to collect physiologic (e.g. heart rate) and other data (e.g. activity, sleep), continuously during their approximately six-month study participation. In addition to collecting data, and similar to the in-person program, the app will have the capability of delivering helpful features, such as information and activities around nutrition, meditation and mindfulness features to best support warfighters, mitigate degradation, and optimize performance. The overall objective of the proposal is to investigate whether a digital version of the in-person cORA program can be created to reduce "red-line" behavioral events (e.g. injury, suicide, divorce, DUI, etc.) specifically, or overall warfighter degradation more generally, can be predicted from daily continuous measures of physical and mental behavior. We will recruit the following: 1) 250 warfighters from 3rd Special Forces Group (SFG(A)) (Fort Bragg, NC) and 2) 250 warfighters from 1st Recon Battalion (Camp Pendleton, CA). These are both elite military warfighting groups. 3rd SFG(A) will be enrolled within 3months of returning from deployment (e.g. the Red Cycle), while Reconnaissance Marines will be enrolled up to 6 months prior to deployment during combat training (e.g. individual and unit training phases (ITP/UTP)). The research will allow collection of a comprehensive dataset of continuous physical and mental factors that can be tied to behavioral outcomes, particularly "red-line" events. We will analyze the data with traditional descriptive statistics to understand the structure of the data. We will then analyze the relationship between the various types of data and self-reported red-line events or general behavioral wellbeing/degradation using correlations and multiple regression analyses where appropriate. We will use the multi-faceted and continuous data from the study as a training data set to develop a novel machine-learning algorithm. Therefore, we will extract novel behavioral features from the actively and passively created data from the app.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Military Operations
  • Military Activity
Intervention  ICMJE Device: Study App and Apple Watch
Study App and Apple Watch
Study Arms  ICMJE Experimental: App/Sensor Intervention
All subjects will be enrolled into the same experimental group for the duration of the study
Intervention: Device: Study App and Apple Watch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 18, 2022
Estimated Primary Completion Date January 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Post or Pre-deployment Army and Marine Warfighters in 3rd SFG(A) and 1st Reconnaissance Battalion. Post-deployment (defined as within three months of returning from deployment) for 3rd SFG(A) and within six months prior to deployment for 1st Reconnaissance Battalion

Exclusion Criteria:

  • Potential participants will be excluded from the study if they are expecting to be in a pre or post operational environment that would not be conducive to study adherence
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04672811
Other Study ID Numbers  ICMJE UP-20-00927
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leslie Saxon, MD, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE Not Provided
PRS Account University of Southern California
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP