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

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ClinicalTrials.gov Identifier: NCT01804257
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Collaborators:
Massachusetts General Hospital
The Zucker Hillside Hospital
Information provided by (Responsible Party):
Proteus Digital Health, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Schizophrenia Other: Digital Health Feedback System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01804257


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116
United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Proteus Digital Health, Inc.
Massachusetts General Hospital
The Zucker Hillside Hospital
Investigators
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Principal Investigator: John M Kane, MD The Zucker Hillside Hospital
More Information
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Publications of Results:

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Responsible Party: Proteus Digital Health, Inc.
ClinicalTrials.gov Identifier: NCT01804257    
Other Study ID Numbers: EMITTER 3.0 PSY
First Posted: March 5, 2013    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: March 2013
Keywords provided by Proteus Digital Health, Inc.:
Adherence
Bipolar disorder
Cellular phone
Cloud computing
Computers
Computers, handheld
Digital health
Digital health feedback system
Ingestion Sensor
Medication adherence
Medication non-adherence
 Medication nonadherence
Mobile phone
Mobile health
Patient adherence
Patient non-adherence
Patient nonadherence
Schizophrenia
Telehealth
Telemedicine
Telenursing
Wearable sensor
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders