Automating Directly Observed Therapy as a Platform Technology

描述（由申请人提供）：简介：Ai Cure Technologies LLC成立于2009年，旨在使用计算机视觉技术开发自动化药物依从性监测解决方案。SBIR第二阶段将允许Ai Cure Technologies测试其旗舰产品AiView的准确性和有效性。SBIR第一阶段证明了AiView "平台在技术上是可行的，能够确认药物给药。意义：不良的用药依从性是临床研究和临床实践的巨大负担。无法准确测量或改善依从性显著加剧了问题。临床试验依赖于人们服用正在测试的药物。药物依从性的问题已经得到解决--依从性的决定因素正在研究，新的监测方法正在开发--但还没有解决方案能够准确确认实时药物依从性，同时又经济实惠、灵活且讨人喜欢。产品：Ai Cure Technologies将提供自动DOT（直接观察治疗）软件平台“AiView”，用于临床试验，该平台在支持网络摄像头的智能手机或平板电脑上使用复杂的计算机视觉技术，以视觉方式确认药物给药。AiView "将在没有人类监督的情况下视觉跟踪和确认药物管理。长期目标："AiView"系统将联合收割机先进的计算机视觉技术与DOT的最佳属性相结合，成本仅为1/400。自动化和标准化药物依从性的捕获方式将有助于临床试验更好地定义受试者的依从率，并允许他们在不依从的情况下立即进行干预。第二阶段假设：“AiView”可用于准确测量和改善不同患者人群的药物依从性，并对自我认知和临床结果产生积极影响。具体目标1：证明AiView系统可以准确测量和改善抑郁症和中风患者人群的药物依从性。具体目标#2：为了证明AiView "系统可以改善自我感知并改善AiView"干预组的临床结局。预期结局：AiView "干预组（抑郁症和中风）的患者预期具有统计学显著高于药丸计数组的患者的依从率。

DESCRIPTION (provided by applicant): Introduction: Ai Cure Technologies LLC was established in 2009 to develop automated medication adherence monitoring solutions using computer vision technology. This SBIR Phase II will allow Ai Cure Technologies to test the accuracy and validity of its flagship product, AiView". The SBIR Phase I demonstrated that the AiView" platform was technically feasible and capable of confirming medication administration. Significance: Poor medication adherence is a huge burden on clinical research and clinical practice. The inability to accurately measure or improve adherence significantly compounds the problem. Clinical trials depend on people taking the drug being tested. The problem of medication adherence has been addressed - determinants of adherence are being studied and new monitoring methods developed - but no solution has been able to accurately confirm real-time medication adherence while also being affordable, flexible, and likable. The Product: Ai Cure Technologies will provide an automated DOT (Directly Observed Therapy) software platform, AiView", for use in clinical trials which uses sophisticated computer vision technology on webcam- enabled smart phones or tablets to visually confirm medication administration. AiView" will visually track and confirm medication administration without human supervision. Long-Term Goal: The AiView" system will combine sophisticated computer vision technology with the best attributes of DOT for 1/400th of the cost. Automating and standardizing the way medication adherence is captured will help clinical trials better define their subjects' rates of compliance and allow them to intervene immediately in case of non-compliance. Phase II hypothesis: AiView" can be used to accurately measure and improve medication adherence across different patient populations, and positively impact self-perception and clinical outcomes. Specific Aim #1: To demonstrate that the AiView" system can accurately measure and improve medication adherence in a depression and a stroke patient population. Specific Aim #2: To demonstrate that the AiView" system can improve self-perception and improve clinical outcomes in the AiView" intervention groups Expected Outcome: The patients in the AiView" intervention groups (depression and stroke) are expected to have statistically significant higher adherence rates than those in the pill counting groups.