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Military OperationsNCT04672811

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

A study testing Study App and Apple Watch in people with Military Operations and Military Activity, run by University of Southern California at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Military Operations, Military Activity
What is being tested?
Study App and Apple Watch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
595 participants
Where
2 sitesUnited States
Study dates
6 Jan 2021to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Ft. Bragg

    Fayetteville, North Carolina, 28310

  • Camp Pendleton

    Oceanside, California, 92058

Other trials in United States

About this study

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

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.

Read the 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, Driving Under the Influence (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.

Being tested
Study App and Apple Watch
Keywords
Military, Deployment, Degradation, Special Operations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study App and Apple WatchDevice

    Study App and Apple Watch

Study groups in NCT04672811
Study groupRoleWhat they receive
App/Sensor InterventionExperimentalAll subjects will be enrolled into the same experimental group for the duration of the study
Receives: Device: Study App and Apple Watch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Warfighter Status

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

    Measured: 6 months

Secondary outcomes (1)
  1. Warfighter Self-Knowledge

    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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start6 Jan 2021
  3. Primary completion30 Nov 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04672811
Sponsor's protocol ID
UP-20-00927
Status last verified
Aug 2026
First submitted
11 Dec 2020
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Study App and Apple Watch in people with Military Operations and Military Activity, run by University of Southern California at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Warfighter Status (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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