Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

NCT01804257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-06-16

Study results available
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Summary

Feasibility study of using a digital health feedback system (DHFS) to monitor medication-taking and physiologic and behavioral parameters in patients with bipolar disorder or schizophrenia. Hypothesis: Using a digital health feedback system to characterize medication-taking behavior and activities of daily living is safe and tolerable in appropriately selected patients with bipolar disorder and schizophrenia.

Conditions

Interventions

OTHER

Digital Health Feedback System

The digital health offering passively collects and records medication-taking behavior and other habits of daily living

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER
  • The Zucker Hillside Hospital

    collaborator OTHER
  • Proteus Digital Health, Inc.

    lead INDUSTRY

Principal Investigators

  • John M Kane, MD · The Zucker Hillside Hospital

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804257 on ClinicalTrials.gov