SBIR-STTR Award

Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression
Award last edited on: 6/21/16

Sponsored Program
SBIR
Awarding Agency
NIH : NIMH
Total Award Amount
$1,495,520
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Skyler Place

Company Information

Cogito Corporation (AKA: Cogito Health Inc)

100 High Street 7th Floor
Boston, MA 02110
   (617) 580-3101
   info@cogitocorp.com
   www.cogitocorp.com
Location: Single
Congr. District: 08
County: Suffolk

Phase I

Contract Number: 1R44MH107065-01
Start Date: 4/1/15    Completed: 3/31/17
Phase I year
2015
Phase I Amount
$748,202
Mood disorders tend to have some of the highest prevalence rates among mental health disorders, and enact high personal, social and economic costs in our country and around the world, presenting a significant public health challenge. Patients often experience low rates of care, worsening their own outcomes. Cogito's mobile application "Cogito Companion" objectively measures behavioral biomarkers via mobile phone sensors and uses these patterns as inputs to predictive models, trained against clinical outcomes. The models predict mental state components of mood disorders. The primary goal of this proposal is to validate the ability of Cogito Companion to passively detect changes in mood disorders in order to improve diagnosis, predict relapse, and measure disease progression in a national sample. This proposal addresses the critical barrier of accurate, objective real-time information on individual mental health. This barrier has prevented individuals from tracking their own disease progression and relapse, from empowering patients to self-manage their chronic symptoms, and from allowing individuals to know when to reach out and access healthcare support. The validation described in this grant proposal will provide patients the ability to have objective, transparent, and continuous metrics of their own mental health. These metrics have never before been available to the patient, in real-time, and with no bias of self -report. Through an observational study of the PCORI-funded and Massachusetts General Hospital-administered Mood Patient Powered Research Network participants, results will be gathered on the relationship of the biomarkers to clinical outcomes. This validation will lead to a successful Phase III commercialization of the technology.

Public Health Relevance Statement:


Public Health Relevance:
Mood disorders have an extremely high prevalence and are incredibly costly to both the individual and society; yet, little is known about how to use biomarkers to detect changes in these disorders. Cogito has developed a technology to objectively assess mood disorder symptomology via novel mobile phone data streams. It is uniquely prepared to provide a means to identify at-risk individuals, improve diagnosis, predict treatment response, and measure disease progression for patients with mood disorders. This Phase II application focuses on validating the ability of this technology to passively calculate episode onset, and symptom change, for those suffering a lifetime prevalence of mood disorders. The success of this project will lead to a Phase III commercial rollout.

Project Terms:
Address; Applications Grants; behavior measurement; Behavior monitoring; Behavioral; behavioral health; Biological Markers; Bipolar Disorder; Car Phone; Caring; Chronic; Clinical; commercialization; Companions; Country; Data; Data Analyses; Data Set; design; Diagnosis; Diagnostic; Disease; Disease Progression; Disease remission; Early Diagnosis; economic cost; empowered; Enrollment; experience; Funding; General Hospitals; Goals; Health Personnel; Health Status; Healthcare; High Prevalence; Hospital Departments; improved; Individual; Institution; Institutional Review Boards; Lead; Major Depressive Disorder; Manic; Marketing; Massachusetts; Measures; Mental disorders; Mental Health; mental state; mobile application; Modeling; Monitor; Mood Disorders; Moods; novel; Observational Study; Outcome; Output; Participant; patient oriented research; Patient Outcomes Assessments; Patient Self-Report; Patients; Pattern; Persons; Phase; Population; predictive modeling; Preparation; Prevalence; prevent; Protocols documentation; Psychiatry; public health medicine (field); public health relevance; Recurrence; Relapse; Reporting; Research; research and development; Risk; Sampling; sensor; single episode major depressive disorder; social; Societies; Staging; Stream; success; Symptoms; System; Technology; Telephone; Testing; Time; tool; Training; treatment response; Validation; Writing

Phase II

Contract Number: 5R44MH107065-02
Start Date: 4/1/15    Completed: 3/31/17
Phase II year
2016
Phase II Amount
$747,318
Mood disorders tend to have some of the highest prevalence rates among mental health disorders, and enact high personal, social and economic costs in our country and around the world, presenting a significant public health challenge. Patients often experience low rates of care, worsening their own outcomes. Cogito's mobile application "Cogito Companion" objectively measures behavioral biomarkers via mobile phone sensors and uses these patterns as inputs to predictive models, trained against clinical outcomes. The models predict mental state components of mood disorders. The primary goal of this proposal is to validate the ability of Cogito Companion to passively detect changes in mood disorders in order to improve diagnosis, predict relapse, and measure disease progression in a national sample. This proposal addresses the critical barrier of accurate, objective real-time information on individual mental health. This barrier has prevented individuals from tracking their own disease progression and relapse, from empowering patients to self-manage their chronic symptoms, and from allowing individuals to know when to reach out and access healthcare support. The validation described in this grant proposal will provide patients the ability to have objective, transparent, and continuous metrics of their own mental health. These metrics have never before been available to the patient, in real-time, and with no bias of self -report. Through an observational study of the PCORI-funded and Massachusetts General Hospital-administered Mood Patient Powered Research Network participants, results will be gathered on the relationship of the biomarkers to clinical outcomes. This validation will lead to a successful Phase III commercialization of the technology.

Public Health Relevance Statement:


Public Health Relevance:
Mood disorders have an extremely high prevalence and are incredibly costly to both the individual and society; yet, little is known about how to use biomarkers to detect changes in these disorders. Cogito has developed a technology to objectively assess mood disorder symptomology via novel mobile phone data streams. It is uniquely prepared to provide a means to identify at-risk individuals, improve diagnosis, predict treatment response, and measure disease progression for patients with mood disorders. This Phase II application focuses on validating the ability of this technology to passively calculate episode onset, and symptom change, for those suffering a lifetime prevalence of mood disorders. The success of this project will lead to a Phase III commercial rollout.

Project Terms:
Address; Applications Grants; behavior measurement; Behavior monitoring; Behavioral; behavioral health; behavioral study; Biological Markers; Bipolar Disorder; Car Phone; Caring; Chronic; Clinical; commercialization; Companions; Country; Data; Data Analyses; Data Set; design; Diagnosis; Diagnostic; Disease; Disease Progression; Disease remission; Early Diagnosis; economic cost; empowered; Enrollment; experience; Funding; General Hospitals; Goals; Health; Health Personnel; Health Status; Healthcare; High Prevalence; Hospital Departments; improved; Individual; Institution; Institutional Review Boards; Lead; Major Depressive Disorder; Manic; Marketing; Massachusetts; Measures; Mental disorders; Mental Health; mental state; mobile application; Modeling; Monitor; Mood Disorders; Moods; novel; Observational Study; Outcome; Output; Participant; patient oriented research; Patient Outcomes Assessments; Patient Self-Report; Patients; Pattern; Persons; Phase; Population; predictive modeling; Preparation; Prevalence; prevent; Protocols documentation; Psychiatry; public health medicine (field); Recurrence; Relapse; Reporting; Research; research and development; Risk; Sampling; sensor; single episode major depressive disorder; social; Societies; Staging; Stream; success; Symptoms; System; Technology; Telephone; Testing; Time; tool; Training; treatment response; Validation; Writing