SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence

项目摘要/摘要 阻塞性睡眠呼吸暂停(OSA)是美国肥胖率上升导致的一个主要公共卫生问题 各州。气道正压(PAP)治疗是个体的首选治疗和“黄金标准”。 伴有中度到重度的阻塞性睡眠呼吸暂停。经常和持续使用PAP可以降低后续疾病的风险，并 提高生活质量。尽管如此，人民行动党的依从率低得离谱。近25%的人停止使用 两周内，一年后50%。大多数PAP遵守计划没有解决自我管理问题 促进遵守的技能和战略，而且往往成本太高、太复杂，无法融入 负担过重的临床环境。此外，他们不会利用机会来改变生活方式 在24小时范围内发生的行为(即睡眠卫生、久坐行为、体力活动)，即 承诺改善OSA症状和PAP依从性。我们的团队之前已经开发出了 成功测试了BeWell24，这是一款使用基于证据的行为改变的多组件智能手机“应用” 改善睡眠、久坐和身体活动行为的策略。我们将增强此应用程序以创建 SleepWell24.增强将包括：(1)基于证据的具体行为改变策略 促进PAP依从性的睡眠呼吸暂停自我管理计划；(2)患者交流界面 数据，以促进患者与提供者就治疗进展进行沟通；以及(3)通过无线实时反馈 集成了基于消费者的PAP机器和可穿戴传感器。这项工作的方方面面，来自APP 从设计/开发到方案交付和评估，将嵌入亚利桑那州梅奥诊所 睡眠医学中心和相关的初级保健诊所，以提高未来临床的可能性 领养。我们将在新处方的PAP用户中测试SleepWell24的效果，并收集有关 与常规护理对照组相比，使用SleepWell24的可行性和可接受性。我们将进行一项 试点随机对照试验，参与者随机分配到(1)SleepWell24；或(2)常规护理 PAP处方后60天。我们将跟踪招聘/留存率、应用程序使用统计数据(例如 使用、使用特定APP功能)，获得患者治疗满意度的有效测量， 患者-提供者沟通，并在临床提供者和患者之间进行定性访谈。我们 将客观地衡量PAP的遵守情况，以测试SleepWell24组是否会有更多的小时/夜晚 PAP使用率与常规护理组比较。以一种探索性的方式，并由我们新开发的 概念模型，我们还将检查SleepWell24对选定治疗结果的影响(体重， 日间嗜睡、认知障碍和与健康相关的生活质量)，并评估假定的社会 SleepWell24对PAP依从性的认知和生活方式行为中介。这项研究代表了一个 为较低的PAP遵从率确定可扩展解决方案的重要一步，并将提供科学 以证明更大规模的临床试验是合理的。

PROJECT SUMMARY / ABSTRACT Obstructive sleep apnea (OSA) is a major public health concern driven by rising rates of obesity in the United States. Positive airway pressure (PAP) therapy is the treatment-of-choice and “gold standard” for individuals with moderate-to-severe OSA. Regular and sustained PAP use can reduce risk for subsequent disease and improve quality of life. Nevertheless, PAP adherence rates are abysmally low. Nearly 25% discontinue use within two weeks and 50% by one year. Most PAP adherence programs do not address the self-management skills and strategies that promote adherence and are often too costly and complex to integrate into overburdened clinical environments. Furthermore, they do not leverage opportunities to change lifestyle behaviors that occur across the 24h spectrum (i.e., sleep hygiene, sedentary behavior, physical activity), which have promise to improve OSA symptoms and PAP adherence. Our team has previously developed and successfully tested BeWell24, a multicomponent smartphone “app” that uses evidence-based behavior change strategies to improve sleep, sedentary, and physical activity behaviors. We will enhance this app to create SleepWell24. Enhancements will include: (1) specific behavior change strategies from the evidence-based Sleep Apnea Self-Management Program to promote PAP adherence; (2) an interface for exchange of patient data to facilitate patient-provider communication on treatment progress; and (3) real-time feedback via wireless integration with a consumer-based PAP machine and wearable sensor. All aspects of this work, from app design/development to program delivery and evaluation, will be embedded within the Mayo Clinic Arizona Center for Sleep Medicine and associated primary care based clinics to enhance likelihood of future clinical adoption. We will test the effects of SleepWell24 in newly prescribed PAP users and gather data on the feasibility and acceptability of using SleepWell24 compared to a usual care control group. We will conduct a pilot randomized controlled trial with participants randomly assigned to (1) SleepWell24; or (2) usual care for 60 days post-PAP prescription. We will track recruitment/retention rates, app usage statistics (e.g., min/day of use, use of specific app functions), obtain validated measures of treatment satisfaction among patients, patient-provider communication, and conduct qualitative interviews among clinical providers and patients. We will objectively measure PAP adherence to test whether the SleepWell24 group will have more hours/night of PAP usage compared to the usual care group. In an exploratory fashion and driven by our newly developed conceptual model, we will also examine the effect of SleepWell24 on selected treatment outcomes (weight, daytime sleepiness, cognitive impairment, and health-related quality of life) and evaluate putative social cognitive and lifestyle behavior mediators of SleepWell24 on PAP adherence. This study represents an important step in identifying a scalable solution to poor PAP adherence rates and will provide the scientific basis to justify a larger clinical trial.