- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804257
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER3PSY)
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02116
- Massachusetts General Hospital
-
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New York
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Glen Oaks, New York, United States, 11004
- Zucker Hillside Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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.
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4 weeks
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Biometrics
Time Frame: 4 weeks
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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
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4 weeks
|
Usability
Time Frame: 4 weeks
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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.
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4 weeks
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User Experience
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John M Kane, MD, The Zucker Hillside Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Adherence
- Telemedicine
- Schizophrenia
- Medication adherence
- Telehealth
- Bipolar disorder
- Wearable sensor
- Telenursing
- Mobile health
- Patient adherence
- Digital health
- Mobile phone
- Computers, handheld
- Cellular phone
- Computers
- Cloud computing
- Medication non-adherence
- Medication nonadherence
- Digital health feedback system
- Ingestion Sensor
- Patient non-adherence
- Patient nonadherence
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMITTER 3.0 PSY
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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