Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Positive Detection Accuracy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Digital Health Feedback System (DHFS)
Ingestion Sensor, Wearable Sensor
干预措施: Digital Health Feedback System (Other)
结局指标
主要结局
Positive Detection Accuracy
时间窗: 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.
次要结局
- System Safety(8 weeks)