Behavioral Health With Medical ComorbiditiesNCT02167373
Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform
A study testing Cogito Companion Intervention and mobile phone application in people with Behavioral Health With Medical Comorbidities, run by Cogito Health Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the use of a mobile sensing platform in a primary care setting has an effect on provider workflows, patient outcomes, patient engagement, patient self-help behavior, health research, and total cost of care. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Behavioral Health With Medical Comorbidities
- What is being tested?
- Cogito Companion Intervention and mobile phone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 30 Sep 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18 and 70 years of age.
- Speak, understand, and read conversational English.
- Be a current patient of South Huntington Clinic recommended for behavioral health care.
- Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.
Who cannot join
- Planning on permanently leaving Boston during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Huntington Clinic
Jamaica Plain, Massachusetts, 02130
About this study
The purpose of this study is to determine whether the use of a mobile sensing platform in a primary care setting has an effect on provider workflows, patient outcomes, patient engagement, patient self-help behavior, health research, and total cost of care.
- Being tested
- Cogito Companion Intervention, mobile phone application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogito Companion InterventionOther
Also called Cogito Mobile Sensing Platform
mobile phone applicationDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Cogito Companion Intervention. Participants will be provided with a mobile phone application that provides feedback on their mental health. The participants' clinicians will be provided with a desktop application to review their patients' results. Receives: Other: Cogito Companion Intervention; Device: mobile phone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Outcome
Depression will be assessed by the Patient Health Questionnaire-8.
Measured: Change from baseline to six months later
Quality of Life Outcome
Patient reported Schwartz Outcome Scale-10 (SOS-10).
Measured: Change from baseline to six months later
Secondary outcomes (4)
Cost of Care
Cost of care can be measured by proxy, through counts of emergency room visits, hospitalization admissions and days, and hospital re-admissions in the last six months.
Measured: Measured at six months
Patient Engagement
Patient engagement will be assessed through frequency of patient use of the mobile technology, no-show rate at appointments, and completion of treatment homework assignments in the last six months.
Measured: Measured at six months
Self-Help Behavior
Self-help behavior will be measured through change in behavior patterns, usage of the mobile application, and requests for additional resources in the last six months.
Measured: Measured at six months
Clinical Outcome (GAF)
We will use the Global Assessment of Functioning (GAF) to measure overall functioning.
Measured: Change from baseline to six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startNov 2015
- Primary completion31 Aug 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral Health With Medical ComorbiditiesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cogito Health Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Brigham and Women's Hospital, Partners HealthCare
- Responsible party
- Principal investigator, Skyler Place, Cogito Health Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167373
- Sponsor's protocol ID
- 2R44MH100748
- Status last verified
- Jul 2018
- First submitted
- 3 Jun 2014
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform
- ClinicalTrials.gov ID
- NCT02167373
- Acronym / sponsor ID
- 2R44MH100748
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Cogito Health IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Brigham and Women's Hospital, Partners HealthCare
- Study start
- Nov 2015
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 19 Jun 2014 (estimated)
- 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 purpose of this study is to determine whether the use of a mobile sensing platform in a primary care setting has an effect on provider workflows, patient outcomes, patient engagement, patient self-help behavior, health research, and total cost of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Other: Cogito Companion Intervention, Device: mobile phone applicationCogito Companion Intervention. Participants will be provided with a mobile phone application that provides feedback on their mental health. The participants' clinicians will be provided with a desktop application to review their patients' results. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be between 18 and 70 years of age.
- Speak, understand, and read conversational English.
- Be a current patient of South Huntington Clinic recommended for behavioral health care.
- Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.
Key exclusion criteria (1 listed)
- Planning on permanently leaving Boston during the study period.
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 Companion InterventionAlso: Cogito Mobile Sensing Platform | Other | Intervention |
| mobile phone application | Device | Intervention |
Primary outcome
Treatment Outcome
Time frame: Change from baseline to six months later
Depression will be assessed by the Patient Health Questionnaire-8.
Quality of Life Outcome
Time frame: Change from baseline to six months later
Patient reported Schwartz Outcome Scale-10 (SOS-10).
4 secondary outcomes
Cost of Care
Time frame: Measured at six months
Patient Engagement
Time frame: Measured at six months
Self-Help Behavior
Time frame: Measured at six months
Clinical Outcome (GAF)
Time frame: Change from baseline to six months later
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 17 Jul 2018.
- Individual participant dataSharing planned: No
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 Intervention and mobile phone application in people with Behavioral Health With Medical Comorbidities, run by Cogito Health Inc 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 4 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 17 Jul 2018. 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?
Treatment Outcome (time frame: Change from baseline to six months later). 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 17 Jul 2018.