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

Sponsor
University of Southern California (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04672811
Collaborator
United States Department of Defense (U.S. Fed)
500
1
17.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Study App and Apple Watch
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Digital cORA (Comprehensive Operator Readiness Assessment): Comprehensive and Continuous Mental and Physical Status Measurement of Pre- and Post-Deployment Warfighters With Mobile Application
Anticipated Study Start Date :
Jan 18, 2021
Anticipated Primary Completion Date :
Jan 17, 2022
Anticipated Study Completion Date :
Jul 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: App/Sensor Intervention

All subjects will be enrolled into the same experimental group for the duration of the study

Device: Study App and Apple Watch
Study App and Apple Watch

Outcome Measures

Primary Outcome Measures

  1. Warfighter Status [6 months]

    Rate of self-reported incidents characteristic of overall mental or physical degradation

Secondary Outcome Measures

  1. Warfighter Self-Knowledge [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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Southern California
  • United States Department of Defense

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leslie Saxon, MD, Principal Investigator, University of Southern California
ClinicalTrials.gov Identifier:
NCT04672811
Other Study ID Numbers:
  • UP-20-00927
First Posted:
Dec 17, 2020
Last Update Posted:
Jan 11, 2021
Last Verified:
Jan 1, 2021
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
Keywords provided by Leslie Saxon, MD, Principal Investigator, University of Southern California

Study Results

No Results Posted as of Jan 11, 2021