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.
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
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
28
The digital health offering passively collects and records medication-taking behavior and other habits of daily living
Massachusetts General Hospital
Boston, Massachusetts, United States
Zucker Hillside Hospital
Glen Oaks, New York, United States
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.
Time frame: 4 weeks
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
Time frame: 8 weeks
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