SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence

SleepWell24：一款创新的智能手机应用程序，可提高 PAP 依从性

• 批准号: 9331748
• 负责人: Matthew P Buman
• 金额: $ 19.53万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9331748
• 关键词: Adherence; Adoption; Adult; Ambulatory Care Facilities; American; Arizona; Behavior; Behavioral; Caring; Cellular Phone; Cessation of life; Chronic Disease; Clinic; Clinical; Clinical Trials; Cognitive; Communication; Complex; Control Groups; Coupled; Data; Development; Devices; Disease; Drowsiness; Ensure; Environment; Evaluation; Feedback; Fostering; Future; Goals; Gold; Head; Health; Health Benefit; Health Care Costs; Hour; Hygiene; Impaired cognition; Individual; Intervention; Interview; Knowledge; Life Style; Measures; Mediator of activation protein; Medicine; Modeling; Monitor; Obesity; Obstructive Sleep Apnea; Outcome; Outpatients; Overweight; Participant; Patient Care; Patient Recruitments; Patients; Pattern; Physical activity; Population; Prevalence; Primary Health Care; Provider; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Recruitment Activity; Risk; Risk Factors; Rural; Self Efficacy; Self Management; Sleep; Sleep Apnea Syndromes; Specialist; Stroke; Subgroup; Surveys; Symptoms; Technology; Testing; Time; Treatment Effectiveness; Treatment outcome; United States; Weight; Wireless Technology; Work; base; behavior change; cardiovascular disorder risk; clinical practice; clinical risk; cloud based; cognitive performance; cost; design; ethnic minority population; evidence base; glucose metabolism; health related quality of life; high risk; improved; innovation; mHealth; medically underserved; novel; premature; pressure; programs; retention rate; satisfaction; sedentary activity; sedentary lifestyle; sensor; skills; social; standard care; statistics; tool; treatment as usual; treatment choice

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.

项目总结/摘要 阻塞性睡眠呼吸暂停（OSA）是一个主要的公共卫生问题，由美国肥胖率的上升所驱动。 States.气道正压通气（PAP）治疗是治疗的选择和“金标准”的个人 中度至重度阻塞性睡眠呼吸暂停综合征定期和持续使用PAP可以降低后续疾病的风险， 提高生活质量。然而，PAP的坚持率非常低。近25%停止使用 在两周内，一年内50%。大多数PAP坚持程序不解决自我管理 这些技能和策略促进了依从性，而且往往过于昂贵和复杂，难以融入 超负荷的临床环境。此外，他们没有利用机会改变生活方式 在24小时频谱上发生的行为（即，睡眠卫生、久坐行为、体力活动）， 有望改善OSA症状和PAP依从性。我们的团队以前开发过， 成功测试了BeWell 24，这是一款多功能智能手机“应用程序”，使用基于证据的行为改变 改善睡眠、久坐和体力活动行为的策略。我们将增强这个应用程序， SleepWell24.增强将包括：（1）从循证的具体行为改变策略 睡眠呼吸暂停自我管理计划，以促进PAP的依从性;（2）交换患者的接口 数据，以促进患者-提供者关于治疗进展的通信;以及（3）经由无线通信的实时反馈。 与基于消费者的PAP机器和可穿戴传感器集成。这项工作的各个方面，从应用程序 从设计/开发到项目交付和评估，将嵌入亚利桑那州的马约诊所 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 领养我们将测试SleepWell 24在新处方PAP使用者中的效果，并收集有关 与常规护理对照组相比，使用SleepWell 24的可行性和可接受性。我们将进行 试验性随机对照试验，受试者随机分配至（1）SleepWell 24;或（2）常规护理 PAP处方后60天。我们将跟踪招聘/保留率、应用程序使用统计数据（例如，分钟/天 使用，特定APP功能的使用），获得患者中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 将客观地测量PAP依从性，以测试SleepWell 24组是否会有更多的小时/夜， PAP使用与常规护理组相比。以探索的方式，由我们新开发的 概念模型，我们还将检查SleepWell 24对选定治疗结果（体重， 日间嗜睡、认知障碍和健康相关的生活质量），并评估假定的社会 SleepWell 24对PAP依从性的认知和生活方式行为介导。这项研究代表了一个 在确定一个可扩展的解决方案，以穷人的PAP坚持率的重要一步，并将提供科学的 为更大规模的临床试验提供依据。

项目成果

Rationale, design, and development of SleepWell24: A smartphone application to promote adherence to positive airway pressure therapy among patients with obstructive sleep apnea.

• DOI: 10.1016/j.cct.2019.105908
• 发表时间: 2020-03
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Petrov ME;Hasanaj K;Hoffmann CM;Epstein DR;Krahn L;Park JG;Hollingshead K;Yu TY;Todd M;St Louis EK;Morgenthaler TI;Buman MP
• 通讯作者: Buman MP