Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform

Study Overview
=================
Brief 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.

Official Title
-----------------
Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform

Conditions
-----------------
Behavioral Health With Medical Comorbidities

Intervention / Treatment
-----------------
* Other: Cogito Companion Intervention
* Device: mobile phone application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Planning on permanently leaving Boston during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Intervention<br>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. | Other: Cogito Companion Intervention<br> <br> * Other names: Cogito Mobile Sensing Platform;Device: mobile phone application<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Outcome | Depression will be assessed by the Patient Health Questionnaire-8. | Change from baseline to six months later | 
| Quality of Life Outcome | Patient reported Schwartz Outcome Scale-10 (SOS-10). | Change from baseline to six months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 at six months | 
| Clinical Outcome (GAF) | We will use the Global Assessment of Functioning (GAF) to measure overall functioning. | Change from baseline to six months later |