Respiratory Oxygen Adherence Monitor for COPD Patients

项目摘要/摘要 简介：呼吸氧依从性监测仪(ROAM)系统将提供一种有效、实用、 和负担得起的方法，可靠地评估和改善长期氧疗(LTOT)的依从性。 需要解决的问题：慢性阻塞性肺疾病(COPD)超过15人 美国；该病每年导致500,000多人住院，100,000多人死亡。LTOT， 通常通过连接到氧气源的鼻插管给患者使用，是唯一的 已被证明可提高因心肺疾病引起的严重低氧血症患者的存活率的治疗。这个 当每天至少使用16小时氧疗时，死亡率的改善最大。LTOT也与 住院人数和住院时间显著减少，生活质量得到改善。尽管 LTOT的好处，对大多数患者来说，依从性仍然是一个挑战。此外，准确评估 患者对LTOT的依从性受到当前技术的限制，所有这些技术都无法识别患者是否 实际上戴着鼻插管吸入氧气，而不是仅仅打开氧气源 在……上面。目前的措施也未能提供关于每24小时氧气使用模式的信息 时间间隔。需要一种客观和准确的方法来衡量患者对LTOT的依从性 提高临床疗效和改善预后。 第一阶段的结果：在第一阶段的工作中，开发了一个漫游系统原型，并得到了高度验证 准确判断使用者何时戴上鼻插管并吸入氧气。记录的数据 包括每分钟遵守与不遵守的分类，这提供了所需的和相关的 有关使用模式和总体遵守时间的信息。 第二阶段假设：SBIR第二阶段计划将测试遵守反馈提供给 患者通过漫游系统，其中包括每天的脉搏血氧饱和度测量(关键健康状态 指标)，将提高对LTOT的遵从性。 第二阶段总结：在拟议的SBIR第二阶段工作中，团队将开发商业就绪的漫游 系统使用精细化的硬件组件，并包含软件界面，使患者和 授权医疗保健提供者访问遵从性数据，包括脉搏血氧仪测量。系统将 为患者提供信息反馈、关注反馈和激励反馈，以鼓励和改进 坚持不懈。拟议的努力还将验证下一代漫游系统的准确性和可用性， 并将在COPD患者中进行一项随机、对照的现场试验，以证明系统的有效性。 公共健康影响：ROAM系统将增加LTOT的遵从性，导致改善 ，并降低与昂贵和 因不遵守规定而可预防的住院治疗。

PROJECT SUMMARY/ABSTRACT Introduction: The Respiratory Oxygen Adherence Monitor (ROAM) system will provide an effective, practical, and affordable method to reliably assess and improve long-term-oxygen therapy (LTOT) adherence. Problem to be Addressed: Chronic obstructive pulmonary disease (COPD) over 15 people in the United States; the condition causes more than 500,000 hospitalizations and over 100,000 deaths annually. LTOT, which is generally administered to patients via a nasal cannula attached to an oxygen source, is the only treatment that has been shown to improve survival in severe hypoxemia due to cardiopulmonary disease. The improvement in mortality is greatest when oxygen therapy is used at least 16 hours/day. LTOT is also associated with significant reductions in hospitalizations and lengths of stay, and improved quality of life. Despite the benefits of LTOT, adherence remains a challenge for most patients. Furthermore, the ability to accurately assess patient LTOT adherence is limited by current technology, all of which fail to discern whether the patient is actually wearing the nasal cannula and inhaling oxygen, as opposed to merely having the oxygen source turned on. Present measures also fail to provide information regarding the pattern of oxygen use for each 24-hour interval. An objective and accurate method for measuring patient adherence to LTOT is required to increase clinical effectiveness and improve outcomes. Phase I Results: During the Phase I effort, a ROAM system prototype was developed and verified to be highly accurate at determining when the user was wearing the nasal cannula and inhaling oxygen. The data recorded include minute-by-minute classifications for adherence vs. non-adherence, which provide required and relevant information regarding patterns of usage and overall adherence times. Phase II Hypothesis: The SBIR Phase II program will test the hypothesis that adherence feedback provided to patients by the ROAM system, which includes daily pulse oximetry measurements (a critical health status metric), will result in increased adherence to LTOT. Phase II Summary: In the proposed SBIR Phase II effort, the team will develop a commercial-ready ROAM system using refined hardware components and the inclusion of a software interface that enables patients and authorized healthcare providers to access adherence data, including pulse oximetry measures. The system will provide patients with informational, attentional, and motivational feedback to encourage and improve adherence. The proposed effort will also verify the accuracy and usability of the next-generation ROAM system, and will culminate with a randomized, controlled field trial with COPD patients to demonstrate system efficacy. Public Health Impact: The ROAM system will increase LTOT adherence, lead to improved outcomes for patients with cardiopulmonary disease, and reduce the healthcare costs that are associated with expensive and preventable hospitalizations due to non-adherence.