mHealth for Patient Self-Management of Opioid Use Disorder

mHealth 用于阿片类药物使用障碍患者的自我管理

• 批准号: 10325362
• 负责人: Jennifer Sharpe Potter
• 金额: $ 86.69万
• 依托单位: BIOMEDICAL DEVELOPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325362
• 关键词: Absenteeism; Acute; Address; Anxiety; Behavior; Behavior Therapy; Behavioral; Client satisfaction; Clinic; Clinical; Clinical Trials; Combined Modality Therapy; Complex; Computer software; Conflict (Psychology); Counseling; Data; Development; Device Approval; Doctor of Medicine; Doctor of Philosophy; Drug usage; Economic Burden; Economics; Effectiveness; Ensure; Epidemic; Evidence based intervention; FDA approved; Feedback; Focus Groups; Food and Drug Administration Device Approval; Goals; Good Clinical Practice; Health; Health Care Costs; Health Services Accessibility; Individual; Intervention; Maps; Measures; Medical; Medical Device; Modification; Moods; Morbidity - disease rate; National Institute of Drug Abuse; Opiate Addiction; Opioid; Overdose; Pain; Participant; Patient Self-Report; Patients; Pattern; Persons; Pharmaceutical Preparations; Phase; Principal Investigator; Process; Psychological reinforcement; Public Health; Quality Control; Quality of life; Randomized; Randomized Controlled Trials; Recovery; Recurrence; Regulation; Reporting; Research Personnel; Safety; Security; Self Management; Small Business Technology Transfer Research; Social Problems; Software Design; Software Engineering; Supportive care; Symptoms; System; Systems Theory; Technology; Testing; Therapeutic; Time; United States; addiction; base; commercialization; control theory; cost; craving; depressive symptoms; design; digital health; effectiveness study; experience; handheld mobile device; illicit opioid; improved; improved outcome; individual patient; innovation; lifestyle intervention; mHealth; medication-assisted treatment; mobile application; mortality; novel; opioid abuse; opioid epidemic; opioid use disorder; patient oriented; personalized approach; phase 1 study; prescription opioid; public health emergency; response; satisfaction; social; software systems; standard of care; success; tool; trial design; usability

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

项目摘要 /摘要 阿片类药物危机是一种流行病，对联合的健康，社会和经济后果造成了毁灭性的流行 国家。从1999年至2018年，近450,000人死于过量涉及任何阿片类药物，包括 处方和非法阿片类药物。全球有300万美国公民和1600万个人或 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燃烧是 估计每年超过2000亿美元。 OUD的治疗涉及药物辅助治疗（MAT）与咨询或行为相结合 治疗疾病，实现和维持更好的健康并改善生活质量的治疗。复发率 吸毒很高，获得咨询的机会有限且昂贵。 MAT是护理标准，高度 有效地降低急性发病率和死亡率，量身定制的治疗方法具有 解决患者的药物使用模式以及与药物有关的医学，精神病和社会问题。 尽管存在移动工具来支持OUD处理，但这些产品仅提供通用信息而不是提供 对每个人的当前状态有反应的个性化反馈，以支持他们的个人康复。 在第一阶段，我们开发了使用非线性控制理论的创新软件平台KIO。库 追踪多个相互作用的症状（例如，渴望，情绪，痛苦）来绘制患者轨迹并及时提供 基于证据的干预策略，直接响应患者报告的需求。可通过移动设备访问 设备，库式为患者提供了需求个性化的建议，并加强了生活方式干预措施 改善垫子期间的自我管理。 I期Beta测试显示钥匙显着降低 OUD症状和高水平的参与度，可用性和患者满意度。 该项目完成了适用于FDA的处方数字保健疗法的开发 批准伴随MAT治疗Oud。这种帮助患者管理的创新工具具有潜力 对公共卫生产生深远的影响并取得巨大的商业成功。这个II期STTR 研究具有三个特定目标，旨在获得FDA医疗设备批准： 特定目标1：增强软件设计和功能 特定目标2：遵守监管要求 特定目标3：在一项为期12周的随机对照试验中评估信息亭