Facilitating Assessment of At-Risk Sailors Using Technology (FAAST)

VA Eastern Colorado Health Care System

Status: Completed

Conditions: Psychological Distress

Treatments: Device: Experimental - Cogito Companion; Behavioral: Active Control

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04159480

18-2844

Details and patient eligibility

About

Randomized clinical trial with individuals being allocated to experimental (Cogito Companion) or Active Control arms. Those in the latter will receive information regarding widely available mobile self-help apps via a custom mobile app built in MyCAP. This same platform will be used to collect data regarding symptoms. Randomization will be stratified by gender, force (Surface, Aviation), and smartphone model (Android, I-Phone), as Cogito algorithms differ based on smartphone platforms. Participants will be willing Naval personnel being redeployed to CONUS. Data is also being collected (feasibility/acceptability) to inform future implementation..

Enrollment: 279 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria.

• Member of the Navel Surface or Aviation Forces;
• Age: 18-55 years at the time of enrollment;
• Ability to provide verbal and electronic informed consents;
• Ownership of smartphone;
• Willingness to use smartphone and personal data plan to participate.

Exclusion Criteria.

• Having redeployed (returning to the Continental United States) more than twelve months (approximately) prior to consent.
• Having an iPhone (until later in 2019 when the Cogito Corporation plans to release the iOS version of the Cogito Companion app).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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279 participants in 2 patient groups

Experimental - Cogito Companion

Experimental group

Description:

Those allocated to Experimental arm will have access the Cogito Companion for a three-month period post-consent. Passive data collection will also occur during this period. As a secure, privacy-compliant mobile app, the Cogito Companion facilitates the non-invasive collection, transfer, integration, analysis, and reporting of objective behavioral indicators. The Cogito mobile sensing platform passively gathers behavioral information through an individual's normal smartphone usage. Measurements of location, call, and text patterns are recorded.

Treatment:

Device: Experimental - Cogito Companion

Active Control

Active Comparator group

Description:

Participants randomized to the Active Control group will download MyCAP and have access to resources housed within this app for a three-month period post-consent. Participants will be provided information regarding the mHealth Tool apps, and provided basic information on how to download the apps. As noted above, participants will be provided biweekly surveys .

Treatment:

Behavioral: Active Control