Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bipolar Disorder, Schizophrenia

Intervention / Treatment
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* Other: Digital Health Feedback System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Health Feedback System (DHFS)<br>Ingestion Sensor, Wearable Sensor | Other: Digital Health Feedback System<br>* The digital health offering passively collects and records medication-taking behavior and other habits of daily living<br>* Other names: Wearable sensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, 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, Telemedicine, Telenursing, Wearable sensor