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

Primary Purpose

Bipolar Disorder, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Health Feedback System
Sponsored by
Proteus Digital Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bipolar Disorder focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Digital Health Feedback System (DHFS)

Arm Description

Ingestion Sensor, Wearable Sensor

Outcomes

Primary Outcome Measures

Positive Detection Accuracy
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

System Safety
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

Full Information

First Posted
February 27, 2013
Last Updated
April 3, 2017
Sponsor
Proteus Digital Health, Inc.
Collaborators
Massachusetts General Hospital, The Zucker Hillside Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01804257
Brief Title
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study
Acronym
EMITTER3PSY
Official Title
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proteus Digital Health, Inc.
Collaborators
Massachusetts General Hospital, The Zucker Hillside Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Schizophrenia
Keywords
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Health Feedback System (DHFS)
Arm Type
Experimental
Arm Description
Ingestion Sensor, Wearable Sensor
Intervention Type
Other
Intervention Name(s)
Digital Health Feedback System
Other Intervention Name(s)
Ingestible sensor, Wearable sensor
Intervention Description
The digital health offering passively collects and records medication-taking behavior and other habits of daily living
Primary Outcome Measure Information:
Title
Positive Detection Accuracy
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
System Safety
Description
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
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Taking and Scheduling Adherence
Description
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.
Time Frame
4 weeks
Title
Biometrics
Description
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
Time Frame
4 weeks
Title
Usability
Description
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.
Time Frame
4 weeks
Title
User Experience
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Kane, MD
Organizational Affiliation
The Zucker Hillside Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Facility Name
Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23842023
Citation
Kane JM, Perlis RH, DiCarlo LA, Au-Yeung K, Duong J, Petrides G. First experience with a wireless system incorporating physiologic assessments and direct confirmation of digital tablet ingestions in ambulatory patients with schizophrenia or bipolar disorder. J Clin Psychiatry. 2013 Jun;74(6):e533-40. doi: 10.4088/JCP.12m08222.
Results Reference
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Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

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