Automating Directly Observed Therapy as a Platform Technology

简介：Ai Cure Technologies LLC成立于2009年，利用计算机视觉技术开发自动化药物依从性监测解决方案。该SBIR II期将允许Ai Cure Technologies测试其旗舰产品AiView的准确性和有效性。SBIR一期试验表明，AiView平台在技术上是可行的，能够确认给药。意义：药物依从性差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地使问题复杂化。临床试验依赖于人们服用被测试药物。坚持服药的问题已经得到了解决——坚持服药的决定因素正在研究中，新的监测方法也在开发中——但没有一种解决方案能够准确地确认实时坚持服药，同时又能负担得起、灵活、讨人喜欢。产品：Ai Cure Technologies将提供一个自动化的DOT（直接观察治疗）软件平台“AiView”，用于临床试验，该平台在具有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，从视觉上确认药物管理。“AiView”将在没有人工监督的情况下可视化地跟踪和确认药物管理。长期目标：“AiView”系统将先进的计算机视觉技术与DOT的最佳属性相结合，成本仅为其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，并允许他们在不遵守的情况下立即进行干预。II期假设：“AiView”可用于准确测量和改善不同患者群体的药物依从性，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的药物依从性。具体目标2：证明“AiView”系统可以改善“AiView”干预组的自我认知和临床结果预期结果：“AiView”干预组（抑郁症和中风）患者的依从率预计比药片计数组有统计学显著性更高。

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.