Quantified Mobile Sensing for Improving Diagnosis and Mea... | NCT02742064

Studies
Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

NCT02742064

Sponsor

Cogito Health Inc

Status

Completed

Last Update Posted

Jul 17, 2018Actual

Enrollment

899Actual

Phase

Not provided

Conditions

Depression
Bipolar Disorder

Interventions

Cogito Companion Mobile Phone Application

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Mar 31, 2018Actual

First Submitted Date

Apr 11, 2016

First Submission Date that Met QC Criteria

Apr 13, 2016

First Posted Date

Apr 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2018

Last Update Posted Date

Jul 17, 2018Actual

Name	Class
Massachusetts General Hospital	OTHER
Partners HealthCare	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time. Meeting this goal will allow for improved risk categorization, prediction of relapse, and measurement of disease progression in a lifetime prevalence population.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

899Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
MDD-Single Episode	1. Subjects who have experienced 1 episode of major depressive disorder (MDD) in their lifetime.	Other: Cogito Companion Mobile Phone Application
MDD-Recurrent	1. Subjects who have experienced 2 or more episodes of depressive disorder (MDD) in their lifetime.	Other: Cogito Companion Mobile Phone Application
Bipolar Disorder	1. Subjects who have been diagnosed with bipolar disorder in their lifetime.	Other: Cogito Companion Mobile Phone Application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cogito Companion Mobile Phone Application	Other		Bipolar Disorder MDD-Recurrent MDD-Single Episode

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of MDD symptoms as assessed by QIDS SR		6 months
Severity of Mania symptoms as assessed by ASRM		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older
Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.
Enrolled in the MoodNetwork

Exclusion Criteria:

Report positively on the QIDS-SR suicide item during study intake
Total score greater than 15 on the QIDS-SR during the screening process

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants will be selected from the MoodNetwork, an online network of individuals with mood disorders, which is hosted by MGH. A subset of participants with mood disorders enrolled in MoodNetwork will download Cogito's mobile sensing platform on their mobile phones.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided