event marker ingested to trigger event recorder 3.0 psychiatry study

Conditions: Bipolar Disorder; Schizophrenia

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.

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.

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

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