mHealth for Patient Self-Management of Opioid Use Disorder - Administrative Supplement

用于阿片类药物使用障碍患者自我管理的 mHealth - 行政补充

• 批准号: 10722156
• 负责人: Jennifer Sharpe Potter
• 金额: $ 12.13万
• 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/10722156
• 关键词: Acute; Address; Administrative Supplement; Behavior Therapy; Client satisfaction; Clinical Trials; Combined Modality Therapy; Computer software; Counseling; Drug usage; Economic Burden; Economics; Epidemic; Evidence based intervention; Feedback; Funding; Health; Health Care Costs; Individual; Intervention; Maps; Medical; Moods; Morbidity - disease rate; Opioid; Overdose; Pain; Patients; Pattern; Persons; Pharmaceutical Preparations; Phase; Psychological reinforcement; Public Health; Quality of life; Randomized, Controlled Trials; Recovery; Recurrence; Reporting; Self Management; Social Problems; Symptoms; Testing; Therapeutic; United States; control theory; cost; craving; digital health; digital treatment; efficacy testing; handheld mobile device; illicit opioid; improved; improved outcome; individual patient; innovation; lifestyle intervention; mHealth; medication-assisted treatment; mortality; opioid epidemic; opioid use disorder; personalized approach; phase 2 study; prescription opioid; social; standard of care; 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 an 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. In Phase II studies, we are evaluating KIOS as a prescription digital health therapeutic suitable for FDA approval concomitant to MAT to treat OUD. The Phase II study contains a 12-week randomized controlled trial designed to satisfy requirements to receive FDA 510(k) clearance. Correspondence with the FDA has led to an expansion of the clinical trial to now include a sham app as a comparator to KIOS. This unexpected addition to the clinical trial has led to the filing of this administrative supplement to develop and test the sham app for use in a randomized controlled trial.

项目摘要 /摘要 阿片类药物危机是一种流行病，对健康，社会和经济后果造成了毁灭性的流行 美国。从1999年至2018年，近45万人死于过量涉及阿片类药物， 包括处方和非法阿片类药物。全球300万美国公民和1600万个人 曾经或目前患有绿化疾病（OUD）。绿核酸的总经济燃烧 美国危机估计每年超过2000亿美元。 OUD治疗涉及药物辅助治疗（MAT）与咨询或 管理疾病，实现和维持更好的健康并改善生活质量的行为疗法。 复发率使用率很高，获得咨询的机会有限且昂贵。而垫子是 护理标准和高效降低急性发病率和死亡率，有优势 量身定制的治疗方法旨在解决单个患者的药物使用模式和与药物有关的方法 医学，精神病和社会问题。尽管存在移动工具来支持OUD治疗，但 产品仅提供广义信息，而不是对每种响应的个性化反馈 人的当前状态以支持个人康复。 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。 千座轨迹轨迹多种相互作用的症状（例如，渴望，情绪，疼痛）来绘制患者轨迹和 提供及时的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，信息库为患者提供按需个性化建议和 加强生活方式干预措施以改善垫子中的自我管理。 I期Beta测试 表现出大量降低OUD和高水平参与度，可用性 和患者满意度。 在第二阶段的研究中，我们将沟渠评估为处方数字健康疗法 为了获得FDA的批准，伴随着垫子以治疗Oud。 II期研究包含一个12周的随机研究 对照试验旨在满足获得FDA 510（k）间隙的要求。对应 FDA导致临床试验的扩展为现在，包括一个假应用程序作为与KIO的比较。 临床试验的这种意外增加导致了此行政补充提交给 开发和测试假应用程序在随机对照试验中使用。