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

NCT04672811 | Enrolling By Invitation FDA Device

• 1 other identifier: UP-20-00927
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Military Operations; Military Activity

Keywords

Military; Deployment; Degradation; Special Operations

Outcome Measures

Primary Outcomes (1)

• Warfighter Status

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

  6 months

Secondary Outcomes (1)

• Warfighter Self-Knowledge

  6 months

Study Arms (1)

App/Sensor Intervention

EXPERIMENTAL

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

Device: Study App and Apple Watch

Interventions

Study App and Apple Watch DEVICE

Study App and Apple Watch

App/Sensor Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• United States Department of Defense: collaborator

Study Sites (2)

Camp Pendleton

Oceanside, California, 92058, United States

Location

Ft. Bragg

Fayetteville, North Carolina, 28310, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: January 6, 2021
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)