First Experience With a Wireless System Incorporating Physiologic Assessments and Direct Confirmation of Digital Tablet Ingestions in Ambulatory Patients With Schizophrenia or Bipolar Disorder
First Experience With a Wireless System Incorporating Physiologic Assessments and Direct Confirmation of Digital Tablet Ingestions in Ambulatory Patients With Schizophrenia or Bipolar Disorder
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DOI：
10.4088/jcp.12045tx2c
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发表时间：
2013-06-01
影响因子：
5.3
通讯作者：
Petrides, Georgios
中科院分区：
文献类型：
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作者：
Kane, John M.;Perlis, Roy H.;Petrides, Georgios
目的：表征无线网络系统的可行性和安全性，该系统结合了精神分裂症或双相情感障碍门诊患者的生理评估和数字平板电脑摄入的直接确认。方法：在这项 2010 年 5 月至 2011 年 5 月在美国 2 个学术临床研究中心进行的为期 4 周的观察性研究中，12 名双相情感障碍成人和 16 名精神分裂症成人（均根据 DSM-IV 标准诊断）使用了数字健康反馈系统（DHFS）。所有受试者均采用稳定的口服药物治疗方案。 DHFS 使用数字平板电脑，该平板电脑由嵌入在含有非药物赋形剂的平板电脑中的摄入传感器组成，受试者将其与常规处方药物一起服用。这种数字药片的配方允许摄入传感器在摄入后通过胃液分离和激活，然后将独特的识别信号从摄入传感器传送到佩戴在躯干上的粘性传感器，该传感器自动记录每次数字药片摄入的日期和时间。可穿戴传感器还收集生理测量数据，包括活动和心率。主要研究目的是比较 DHFS 与直接观察摄入的方法在确认数字平板电脑摄入方面的准确性；次要目标包括这些队列中纵向依从性和生理测量的特征。结果：28 名受试者中的 27 名 (96%) 完成了研究。平均依从率为 74% (95% CI, 64%-86%)，67% (95% CI, 55%-79%) 的剂量是在规定给药时间的 2 小时内服用的。每天的活动量为 847 至 15,930 步，睡眠时间为每天 3.2 至 15.2 小时。对于个体受试者来说，在整个研究期间，平均睡眠中断（定义为睡眠事件期间短暂觉醒和姿势变化的数量（例如，受试者在夜间坐起））低至 5%，高达 43%。最常见的不良事件是 5 名受试者 (18%) 在可穿戴传感器部位发生轻微皮肤刺激，但这不会导致提前停药。摄入传感器没有发生任何不良事件。没有受试者因使用 DHFS 而出现精神病恶化。在完成研究的 27 名受试者中，19 名 (70%) 认为 DHFS 概念易于理解，21 名 (78%) 表示他们希望在忘记服药时在手机上收到提醒，24 名 (89%) 认为 DHFS 对他们可能有用。结论：DHFS 提供了一种确认药物摄入和跟踪选定生理参数的新方法，患者普遍耐受性良好。
Objective: To characterize the feasibility and safety of a wireless networked system incorporating physiologic assessments and direct confirmation of digital tablet ingestions in ambulatory patients with schizophrenia or bipolar disorder.Method: 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 formulation of this digital tablet allowed ingestion sensor separation and activation by stomach fluids after ingestion, followed by communication of a unique identifying signal from the ingestion sensor to an adhesive sensor worn on the torso, which automatically logged the date and time of each digital tablet ingestion. The wearable sensor also collected physiologic measures including activity and heart rate. 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.Results: 27 of 28 subjects (96%) completed the study. The mean adherence rate was 74% (95% CI, 64%-86%), and 67% (95% CI, 55%-79%) of doses were taken within 2 hours of the prescribed dosing time. Activity consisted of 847 to 15,930 steps daily, and sleep duration ranged from 3.2 to 15.2 hours daily. For individual subjects, mean sleep disruption, defined as the amount of brief arousals and postural changes during sleep events (eg, subject sitting up during the night), was as low as 5% and as high as 43% for the entire study period. The most common adverse event was minor skin irritation that occurred at the site of the wearable sensor in 5 subjects (18%), which did not lead to early discontinuation. No adverse events occurred due to the ingestion sensor. No subjects developed worsening of psychosis attributable to use of the DHFS. Of the 27 subjects who completed the study, 19 (70%) found the DHFS concept easy to understand, 21 (78%) said they would like to receive reminders on their cell phone if they forgot to take their medications, and 24 (89%) thought the DHFS could be useful to them.Conclusions: The DHFS provided a novel means of confirming medication ingestion and tracking selected physiologic parameters, and it was generally well tolerated by patients.