NCT04150354

Brief Summary

The primary objective of this project is to test the acceptability and feasibility of a mobile application to facilitate mental health symptom monitoring and follow-up among Veterans. During the course of the study, the research application will be installed on participants' mobile phone. The application on the participants' phone will be recording data about their behavior. Participants will also be asked to complete bi-weekly surveys via the app.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

3.2 years

First QC Date

July 23, 2019

Last Update Submit

May 7, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Client Satisfaction Questionnaire -8

    Veterans' satisfaction with app

    3 months

  • Narrative Evaluation of Intervention Interview (NEII).

    Ease of Implementation per Veterans

    3 months

Study Arms (1)

Participants allocated to Cogito Companion

EXPERIMENTAL

Participants 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.

Behavioral: Cogito Companion

Interventions

During the course of the study, the research application (Cogito Companion) will be installed on participants' mobile phone. The application on the participants' phone will be recording data about their behavior. Participants will also be asked to complete bi-weekly surveys via the app.

Participants allocated to Cogito Companion

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans between the ages 18-89 years of age at the time of enrollment
  • able to provide signed and dated informed consent
  • has anandroid platform phone and is willing to use phone and personal data plan to participate

You may not qualify if:

  • Participation in conflicting Rocky Mountain MIRECC interventional protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VAECHCS

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cell Phone UsePatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

CommunicationBehaviorSocial BehaviorTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the VHA Rocky Mountain MIRECC

Study Record Dates

First Submitted

July 23, 2019

First Posted

November 4, 2019

Study Start

October 28, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations