NCT02167373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

June 3, 2014

Last Update Submit

July 16, 2018

Conditions

Behavioral Health With Medical Comorbidities

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Cost of Care

    Measured at six months

  • Patient Engagement

    Measured at six months

  • Self-Help Behavior

    Measured at six months

  • Clinical Outcome (GAF)

    Change from baseline to six months later

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

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 InterventionDevice: mobile phone application

Interventions

Cogito Companion InterventionOTHER
Also known as: Cogito Mobile Sensing Platform
Intervention
mobile phone applicationDEVICE
Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Planning on permanently leaving Boston during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Huntington Clinic

Jamaica Plain, Massachusetts, 02130, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Manager of Advanced Product Development

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 19, 2014

Study Start

November 1, 2015

Primary Completion

August 31, 2017

Study Completion

September 30, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)