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Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

Sponsor
Cogito Health Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02742064
Collaborator
Massachusetts General Hospital (Other), Partners HealthCare (Other)
899
Enrollment
1
Location
37.9
Duration (Months)
23.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cogito Companion Mobile Phone Application

Study Design

Study Type:
Observational
Actual Enrollment :
899 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Mar 31, 2018

Arms and Interventions

Arm Intervention/Treatment
MDD-Single Episode

1. Subjects who have experienced 1 episode of major depressive disorder (MDD) in their lifetime.

Other: Cogito Companion Mobile Phone Application
Other Names:
  • Cogito Mobile Sensing Platform

    		•
    MDD-Recurrent

    1. Subjects who have experienced 2 or more episodes of depressive disorder (MDD) in their lifetime.

    Other: Cogito Companion Mobile Phone Application
    Other Names:
  • Cogito Mobile Sensing Platform

    		•
    Bipolar Disorder

    1. Subjects who have been diagnosed with bipolar disorder in their lifetime.

    Other: Cogito Companion Mobile Phone Application
    Other Names:
  • Cogito Mobile Sensing Platform

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Severity of MDD symptoms as assessed by QIDS SR [6 months]

    2. Severity of Mania symptoms as assessed by ASRM [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Cogito Health Inc
    • Massachusetts General Hospital
    • Partners HealthCare

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cogito Health Inc
    ClinicalTrials.gov Identifier:
    NCT02742064
    Other Study ID Numbers:
    • 1R44MH107065-01
    First Posted:
    Apr 18, 2016
    Last Update Posted:
    Jul 17, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Disease Progression
    Bipolar Disorder

    Study Results

    No Results Posted as of Jul 17, 2018