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Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform

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ClinicalTrials.gov Identifier: NCT02167373
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : July 17, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Brigham and Women's Hospital
Partners HealthCare
Information provided by (Responsible Party):
Skyler Place, Cogito Health Inc

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.

Condition or disease Intervention/treatment Phase
Behavioral Health With Medical Comorbidities Other: Cogito Companion Intervention Device: mobile phone application Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform
Study Start Date : November 2015
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : September 30, 2017

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 Name: Cogito Mobile Sensing Platform

Device: mobile phone application



Primary Outcome Measures :
  1. Treatment Outcome [ Time Frame: Change from baseline to six months later ]
    Depression will be assessed by the Patient Health Questionnaire-8.

  2. Quality of Life Outcome [ Time Frame: Change from baseline to six months later ]
    Patient reported Schwartz Outcome Scale-10 (SOS-10).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167373


Locations
United States, Massachusetts
South Huntington Clinic
Jamaica Plain, Massachusetts, United States, 02130
Sponsors and Collaborators
Cogito Health Inc
National Institute of Mental Health (NIMH)
Brigham and Women's Hospital
Partners HealthCare

Responsible Party: Skyler Place, General Manager of Advanced Product Development, Cogito Health Inc
ClinicalTrials.gov Identifier: NCT02167373     History of Changes
Other Study ID Numbers: 2R44MH100748 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No