Mobile ApplicationsNCT04150354
Mental Health Symptom Monitoring Utilizing the Cogito Behavioral Analytic Platform
A study testing Cogito Companion in people with Mobile Applications and Cell Phone Use, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobile Applications, Cell Phone Use, Mental Health Issue
- What is being tested?
- Cogito Companion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2016to Jan 2020
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in conflicting Rocky Mountain MIRECC interventional protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mobile Applications, Cell Phone Use, Mental Health Issue, Acceptability of Health Care, Feasibility
- Being tested
- Cogito Companion
- Medical subject headings
- Cell Phone Use, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogito CompanionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cogito Companion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire -8
Veterans' satisfaction with app
Measured: 3 months
Narrative Evaluation of Intervention Interview (NEII).
Ease of Implementation per Veterans
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start28 Oct 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile ApplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Lisa Brenner, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150354
- Sponsor's protocol ID
- 16-0109
- Status last verified
- May 2022
- First submitted
- 23 Jul 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Symptom Monitoring Utilizing the Cogito Behavioral Analytic Platform
- ClinicalTrials.gov ID
- NCT04150354
- Acronym / sponsor ID
- 16-0109
- Conditions
- Mobile Applications, Cell Phone Use, Mental Health Issue, Acceptability of Health Care, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- 28 Oct 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants allocated to Cogito Companion | Experimental | Behavioral: Cogito CompanionParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in conflicting Rocky Mountain MIRECC interventional protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogito CompanionDuring 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. | Behavioural | Participants allocated to Cogito Companion |
Primary outcome
Client Satisfaction Questionnaire -8
Time frame: 3 months
Veterans' satisfaction with app
Narrative Evaluation of Intervention Interview (NEII).
Time frame: 3 months
Ease of Implementation per Veterans
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogito Companion in people with Mobile Applications and Cell Phone Use, run by VA Eastern Colorado Health Care System at 1 site 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 3 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Client Satisfaction Questionnaire -8 (time frame: 3 months). The study lists 2 primary outcomes in all. 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 10 May 2022.