Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER3PSY)

April 3, 2017 updated by: Proteus Digital Health, Inc.

Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)

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.

Study Overview

Status

Completed

Detailed Description

In this 4-week observational study conducted between May 2010 and May 2011 at 2 US academic clinical study sites, 12 adults with bipolar disorder and 16 adults with schizophrenia (all diagnosed according to DSM-IV criteria) utilized a digital health feedback system (DHFS). All subjects were on a stable regimen of oral medication. The DHFS utilized a digital tablet, consisting of an ingestion sensor that was embedded in a tablet containing nonpharmacologic excipients, which subjects coingested with their regularly prescribed medication.

The primary study objective was to compare the accuracy of DHFS in confirming digital tablet ingestion versus a method of directly observed ingestion; secondary aims included characterization of adherence and physiologic measures longitudinally in these cohorts.

Study Type

Interventional

Enrollment (Actual)

28

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

    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Massachusetts General Hospital
    • New York
      • Glen Oaks, New York, United States, 11004
        • Zucker Hillside Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female ≥ 18 and ≤ 65 years of age
  • Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, by Structured Clinical Interview using DSM-IV SCID-I/P1, for either:

    i. Bipolar disorder I, II, or Not Otherwise Specified (NOS), or ii. Schizophrenia or schizoaffective disorder

  • Clinical global impression scale-severity (CGI-S) of 3 or below
  • Currently on a stable regimen of oral antimanic or antipsychotic medication for at least 3 months
  • No anticipation to change or titrate the regimen in the next 28 days
  • Willingness to adhere to study procedures
  • Capacity to provide informed consent

Exclusion Criteria:

  • Pregnancy, or women of child bearing potential who are not using a medically accepted means of contraception
  • Serious suicide or homicide risk, as assessed by evaluating clinician
  • Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
  • DSM-IV diagnoses or symptoms of substance use disorders, active within the last 60 days
  • A score of 3 or higher on the suspiciousness/paranoia item of the Brief Psychiatric Rating Scale (BPRS)
  • Acute, clinically significant gastrointestinal symptoms, such as nausea, vomiting, abdominal pain, diarrhea, melena, or hematochezia
  • History of significant gastrointestinal disease or major gastrointestinal surgery
  • Clinical instability of any kind that, in the investigator's opinion, could preclude safe participation in the study
  • Known allergies that could preclude safe participation in the study
  • Current presence of an electronically active implanted medical device
  • Participation in another medical device study, or on any investigational drug or device within the last 30 days
  • Inability to obtain consent

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Health Feedback System (DHFS)
Ingestion Sensor, Wearable Sensor
The digital health offering passively collects and records medication-taking behavior and other habits of daily living
Other Names:
  • Wearable sensor
  • Ingestible sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Detection Accuracy
Time Frame: 4 weeks
Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Safety
Time Frame: 8 weeks
Characterize, using summary (descriptive) statistics, the incidence and nature of system-related adverse events (AEs) and serious adverse events (SAEs) that are reported by study investigators over the course of the study
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taking and Scheduling Adherence
Time Frame: 4 weeks
Characterize, using summary (descriptive) statistics, medication-taking behavior in free-living environment. Taking adherence defined as the number of ingestion sensors detected by the DHFS in the free-living environment, divided by the prescribed (planned) number of ingestions. Scheduling adherence defined as number of ingestion sensors detected by the DHFS within a ± 2-hour time window around the prescribed (planned) dosing time, divided by the total number of ingestion sensors detected by the DHFS.
4 weeks
Biometrics
Time Frame: 4 weeks
Characterize, using summary (descriptive) statistics, heart rate and rest/activity patterns in a free-living environment. Activity defined as the number of hours per day with recorded a recorded step rate ≥ 60 steps per minute
4 weeks
Usability
Time Frame: 4 weeks
Characterize, using summary (descriptive) statistics, the use of the digital health feedback system and its components by patients, caregivers, and healthcare providers. Use captured utilizing numeric scores collected from a standardized instrument, focusing on overall comfort and ease of DHFS use.
4 weeks
User Experience
Time Frame: 4 weeks
Feedback and suggestions from patients, caregivers, and healthcare providers regarding system metrics and summary presentations of medication-taking, biometrics, and activities of daily living. Feedback includes free text and descriptive statistics summarizing numeric scores collected from a standardized instrument focusing on overall satisfaction with the DHFS and its components.
4 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: John M Kane, MD, The Zucker Hillside Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

May 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

March 1, 2013

More Information

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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