Trial Outcomes & Findings for Facilitating Assessment of At-Risk Sailors Using Technology (NCT NCT04159480)

Last Updated: 2025-05-09

Results Overview

To measure the percentage of participants randomized to Cogito who were satisfied, a 'Client Satisfaction Questionnaire' was distributed to participants to complete and return. Responses were collected and evaluated to find the percentage of participant satisfaction.

Recruitment status

COMPLETED

Study phase

Target enrollment

279 participants

Primary outcome timeframe

From Baseline to Follow-Up, Approximately 3 months

Results posted on

2025-05-09

Participant Flow

279 Naval personnel were enrolled and randomized - 139 participants to Cognito Companion and 140 to Active Control

Unit of analysis: Online Assessment

Participant milestones

Participant milestones
Measure	Experimental - Cogito Companion 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. Experimental - Cogito Companion: Cogito Companion	Active Control 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 . Active Control: Use of MyCAP
Overall Study STARTED	139 139	140 140
Overall Study COMPLETED	139 139	140 140
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluated characteristic by group

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cogito n=139 Participants Randomized to Cogito	Active Control n=140 Participants Randomized to Control	Total n=279 Participants Total of all reporting groups
Age, Continuous	28.7 Years STANDARD_DEVIATION 6.8 • n=5 Participants	28.3 Years STANDARD_DEVIATION 6.7 • n=7 Participants	28.5 Years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex/Gender, Customized Gender · Male	109 Participants n=5 Participants • Evaluated characteristic by group	109 Participants n=7 Participants • Evaluated characteristic by group	218 Participants n=5 Participants • Evaluated characteristic by group
Sex/Gender, Customized Gender · Female	28 Participants n=5 Participants • Evaluated characteristic by group	28 Participants n=7 Participants • Evaluated characteristic by group	56 Participants n=5 Participants • Evaluated characteristic by group
Sex/Gender, Customized Gender · Declined	2 Participants n=5 Participants • Evaluated characteristic by group	3 Participants n=7 Participants • Evaluated characteristic by group	5 Participants n=5 Participants • Evaluated characteristic by group
Race/Ethnicity, Customized Race/Ethnicity · Caucasian/White	89 Participants n=5 Participants	82 Participants n=7 Participants	171 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African American	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native American/Alaskan	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Multiple Races	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Declined to Answer	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ranomized to Cogito or Active Control	139 Participants n=5 Participants	140 Participants n=7 Participants	279 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Follow-Up, Approximately 3 months

Population: Participant Satisfaction

Outcome measures

Outcome measures
Measure	Cogito n=40 Participants Randomized to Cogito
Percentage of Cogito Participants Reported Being Satisfied	52 percentage of participants

Adverse Events

Cogito

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Brenner

University of Colorado, Anschutz Medical Campus

Phone: 7208481980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place