mHealth for Patient Self-Management of Opioid Use Disorder

项目概要/摘要 阿片类药物危机是一种流行病，对美国的健康，社会和经济造成了毁灭性的后果。 States.从1999年到2018年，近45万人死于涉及任何阿片类药物的过量，包括 处方药和非法阿片类药物。300万美国公民和全球1600万人已经或 目前患有阿片类药物使用障碍（OUD）。美国阿片类药物危机的总经济负担是 估计每年超过两千亿美元。 OUD的治疗包括药物辅助治疗（MAT）结合咨询或行为治疗。 治疗，以管理疾病，实现和维持更好的健康，并提高生活质量。经常性比率 毒品使用率很高，获得咨询的机会有限而且费用昂贵。虽然MAT是护理标准， 有效降低急性发病率和死亡率，有优势的治疗方法， 解决个别病人的药物使用模式和药物相关的医疗，精神和社会问题。 虽然存在支持OUD治疗的移动的工具，但这些产品仅提供一般信息， 个性化的反馈，响应每个人的当前状态，以支持他们的个人恢复。 在第一阶段，我们开发了KIOS，这是一个使用非线性控制理论的创新软件平台。KIOS 跟踪多个相互作用的症状（例如，渴望，情绪，疼痛），以绘制患者轨迹并及时交付 基于证据的干预策略，直接响应患者报告的需求。可通过移动的 设备，KIOS为患者提供个性化的建议和加强生活方式干预， 提高MAT期间的自我管理能力。第一阶段beta测试表明， OUD的症状和高水平的参与度、可用性和患者满意度。 该项目完成了KIOS作为适用于FDA的处方数字健康治疗药物的开发 批准与MAT同时用于治疗OUD。这种帮助患者管理OUD的创新工具具有潜力 对公众健康产生深远的影响，并取得重大的商业成功。本阶段II STTR 研究有三个特定目的，旨在获得FDA医疗器械批准： 具体目标1：增强软件设计和功能 具体目标2：遵守法规要求 具体目标3：在12周随机对照试验中评价KIOS

PROJECT SUMMARY / ABSTRACT The opioid crisis is an epidemic with devastating health, social, and economic consequences for the United States. From 1999–2018, almost 450,000 people died from an overdose involving any opioid, including prescription and illicit opioids. Three million US citizens and 16 million individuals worldwide have had or currently suffer from opioid use disorder (OUD). The total economic burden of the opioid crisis in the US is estimated to be more than $200 billion annually. Treatment for OUD involves medication assisted treatment (MAT) combined with counseling or behavioral therapy to manage the illness, achieve and sustain better health, and improve quality of life. Rates of recurrent drug use are high, and access to counseling is limited and costly. While MAT is standard of care and highly effective at reducing acute morbidity and mortality, there are advantages to treatment approaches tailored to address an individual patient’s drug use patterns and drug-related medical, psychiatric, and social problems. While mobile tools exist to support OUD treatment, these products offer only generalized information and not personalized feedback that is responsive to each person’s current status to support their individual recovery. In Phase I, we developed KIOS, an innovative software platform using nonlinear control theory. KIOS tracks multiple interacting symptoms (e.g., craving, mood, pain) to map patient trajectories and deliver timely evidence-based intervention strategies, responding directly to patient-reported needs. Accessible via mobile devices, KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during MAT. Phase I beta testing demonstrated significant reductions in key symptoms of OUD and high levels of engagement, usability and patient satisfaction. This project completes development of KIOS as a prescription digital health therapeutic suitable for FDA approval concomitant to MAT to treat OUD. This innovative tool to help patients manage OUD has the potential to have a profound impact on public health and achieve significant commercial success. This Phase II STTR study has three Specific Aims which are designed to attain FDA medical device approval: Specific Aim 1: Enhance Software Design and Features Specific Aim 2: Comply with Regulatory Requirements Specific Aim 3: Evaluate KIOS in a 12-week Randomized Controlled Trial