Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform

July 16, 2018 updated by: Skyler Place, Cogito Health Inc
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Jamaica Plain, Massachusetts, United States, 02130
        • South Huntington Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Intervention
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
Other Names:
  • Cogito Mobile Sensing Platform
Device: mobile phone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Outcome
Time Frame: Change from baseline to six months later
Depression will be assessed by the Patient Health Questionnaire-8.
Change from baseline to six months later
Quality of Life Outcome
Time Frame: Change from baseline to six months later
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
Time Frame: Measured at six months
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
Time Frame: Measured at six months
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
Time Frame: Measured at six months
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)
Time Frame: Change from baseline to six months later
We will use the Global Assessment of Functioning (GAF) to measure overall functioning.
Change from baseline to six months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cogito Health Inc

Collaborators

National Institute of Mental Health (NIMH)
Brigham and Women's Hospital
Partners HealthCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2R44MH100748 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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