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
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Schizophrenia||Other: Digital Health Feedback System||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||28 participants|
|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|
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
- 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.
- 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
- 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.
- 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
- 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.
- 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.
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
|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|
|Principal Investigator:||John M Kane, MD||The Zucker Hillside Hospital|