Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)

实用阻塞性睡眠呼吸暂停减肥试验评估有效性和范围 (POWER)

• 批准号: 10311958
• 负责人: Lucas Matthew Donovan
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-10-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10311958
• 关键词: Address; Adopted; Adoption; Affect; Apnea; Blood Pressure; Body Weight decreased; Caring; Characteristics; Counseling; Data; Diagnosis; Diet; Disease; Disease Management; Effectiveness; Ensure; Evaluation; Family; Future; Geography; Goals; Health; Health Promotion; Health Services Accessibility; Healthcare; Healthcare Systems; Hybrids; Improve Access; Internet; Intervention; Knowledge; Life Style; Link; Lung; Maintenance; Measures; Modeling; Modernization; Nature; Newly Diagnosed; Obesity; Obstructive Sleep Apnea; Outcome; Outcome Measure; Paper; Participant; Patients; Personal Satisfaction; Persons; Physiological; Planning Techniques; Policies; Population; Prevention; Provider; Qualitative Methods; Quality of life; Randomized; Randomized Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Research Design; Resources; Risk; Risk Factors; Schedule; Self-Direction; Service delivery model; Services; Severities; Sleep; Symptoms; System; Technology; Telephone; Testing; Time; Time trend; Translating; Uncertainty; Veterans; Visit; Weight; Weight Gain; Weight maintenance regimen; Work; base; behavior change; budget impact; cardiovascular disorder risk; cardiovascular risk factor; clinical practice; comorbidity; control trial; cost; diabetes prevention program; effectiveness evaluation; effectiveness outcome; effectiveness testing; efficacy trial; follow-up; high risk population; implementation outcomes; implementation process; improved; indexing; innovation; lifestyle intervention; literacy; medical specialties; neglect; novel; outcome prediction; population health; pragmatic trial; pressure; primary endpoint; primary outcome; programs; remote intervention; secondary outcome; telehealth; tool; treatment as usual; virtual healthcare; weight loss intervention; weight loss program

Background: Prevalent obesity related conditions like obstructive sleep apnea (OSA) represent an important opportunity for the VA to improve population health. OSA markedly reduces quality of life and is associated with 3-fold greater risk for cardiovascular disease. Although obesity is the single greatest reversible risk factor for OSA, the 1 million Veterans with OSA and obesity rarely receive weight loss care to reverse OSA and other serious comorbidities. Efficacy trials reinforce that time and resource intensive lifestyle-based weight loss programs improve weight and physiologic measures of OSA severity (apnea hypopnea index, AHI). However, there are barriers to translating these findings into meaningful gains for population health. First, VA has limited capacity to counsel patients around lifestyle change. Less than one-third of Veterans with OSA and obesity are counseled about weight loss and even fewer are referred to weight loss services. Second, VA’s current weight loss offerings are difficult to access. Only 12% of Veterans with OSA and obesity utilize MOVE!, and those referred to MOVE! achieve minimal weight loss—1.2 kg at 1 year. Third, prior weight loss trials focused on intermediate measures (e.g. AHI), limiting understanding of effectiveness for meaningful outcomes. To meet these challenges, we propose a pragmatic trial of proactively offering a remote video-based and self-directed weight loss intervention with telephone-based coaching to Veterans with newly diagnosed OSA. Our weight loss intervention (D-ELITE) is adapted from a program known to be effective in a non-VA population, with 44% of participants achieving ≥5% weight loss at 24 months. Further optimizing reach, our remote intervention includes low-technology options (e.g. DVD videos) to accommodate those with low technology literacy. Significance: Our research tests a program of proactively providing Veterans with OSA the tools to manage weight loss in a way that is independent of local provider time and resources. Our research addresses a key gap in Veteran’s health in a way that aligns with important VA priorities including population health, virtual care, access, and health care value. We anticipate our intervention can efficiently achieve improvements in quality of life while reducing the burden and risk of serious comorbidities. Innovation and Impact: Our research directly challenges the traditional provider-driven model of healthcare delivery where providers direct care and provide necessary services aimed at managing a single disease. Instead, we propose to proactively deliver weight loss services to a high-risk group using a population health approach. In doing so, we will conduct the first trial of remote and self-directed weight loss care in OSA and will test whether weight loss care can improve meaningful outcomes such as quality of life and cardiovascular risk. Specific Aims: Our primary aim is to test the effectiveness of a proactively delivered and pragmatic weight loss intervention to improve co-primary endpoints of sleep-related quality of life and weight among Veterans with OSA and obesity. Secondarily, we will compare additional outcomes between groups: cardiovascular risk scores, sleep symptoms, and AHI. Finally, we will also conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation. Methodology: We plan a hybrid type 1 pragmatic randomized controlled trial. We will proactively identify Veterans with OSA and obesity nationwide using data from the CDW (n=696), randomizing 1:1 to usual care plus the D-ELITE weight loss intervention or usual care alone. We will collect primary outcomes at 12 months, but we will also collect outcomes at 3 and 24 months to assess trends over time. We will use quantitative and qualitative methods to assess barriers to implementation, including a comprehensive budget impact analysis. Next Steps/Implementation: If effective, we will work with our operational partner, the National Center for Health Promotion and Prevention (NCP), to integrate D-ELITE into NCPs suite of weight loss offerings. The National Program Office for Pulmonary/Sleep also agrees to promote policies supporting nationwide adoption.

背景：与肥胖相关的疾病，如阻塞性睡眠呼吸暂停（OSA）， 这是一个改善人口健康的机会。OSA显著降低生活质量， 患心血管疾病的风险高出三倍虽然肥胖是唯一最大的可逆风险因素 对于OSA，100万患有OSA和肥胖症的退伍军人很少接受减肥护理来逆转OSA和其他疾病。 严重的合并症。功效试验加强了时间和资源密集型的生活方式为基础的减肥 计划改善了体重和OSA严重程度的生理指标（呼吸暂停低通气指数，AHI）。然而，在这方面， 要将这些研究结果转化为有益于人口健康的成果，还存在障碍。首先，有限的 为患者提供有关生活方式改变的咨询。不到三分之一的患有OSA和肥胖症的退伍军人 建议减肥，甚至更少的人被称为减肥服务。第二，当前的权重 亏损产品难以获得。只有12%的患有OSA和肥胖症的退伍军人使用MOVE！，和那些 提到MOVE！实现最小的体重减轻-1年时1.2 kg。第三，之前的减肥试验集中在 中间措施（如AHI），限制了对有意义结果的有效性的理解。满足 这些挑战，我们提出了一个务实的审判，主动提供远程视频为基础的和自我指导的 对新近诊断为OSA的退伍军人进行电话指导的减肥干预。我们的体重 损失干预（D-ELITE）改编自一个已知在非VA人群中有效的计划，44% 24个月时体重减轻≥5%的受试者。进一步优化覆盖范围，我们的远程干预 包括低技术选择（如DVD视频），以适应那些技术素养低的人。 意义：我们的研究测试了一项计划，该计划旨在主动为患有OSA的退伍军人提供管理工具。 减肥的方式是独立于当地供应商的时间和资源。我们的研究解决了一个关键问题 退伍军人健康方面的差距与重要的VA优先事项保持一致，包括人口健康，虚拟护理， 和医疗保健价值。我们期望我们的干预能够有效地提高 生活，同时减少严重合并症的负担和风险。 创新和影响：我们的研究直接挑战传统的医疗保健提供者驱动模式 提供服务，即提供者指导护理并提供旨在管理单一疾病的必要服务。 相反，我们建议使用人口健康计划主动向高风险群体提供减肥服务， approach.在这样做的过程中，我们将在OSA中进行第一次远程和自我指导的减肥护理试验，并将 测试减肥护理是否可以改善有意义的结果，如生活质量和心血管风险。 具体目标：我们的主要目标是测试主动交付和务实的重量的有效性 损失干预，以改善退伍军人睡眠相关生活质量和体重的共同主要终点 阻塞性睡眠呼吸暂停综合征和肥胖症其次，我们将比较两组之间的其他结局： 睡眠症状和AHI。最后，我们还将对实施过程进行评估告知 通过RE-AIM框架确定广泛实施的障碍和促进因素。 方法：我们计划进行一项混合1型实用随机对照试验。我们将积极识别 全国范围内患有OSA和肥胖症的退伍军人，使用来自CDW的数据（n=696），按1：1的比例随机分配至常规治疗组 加上D-ELITE减肥干预或单独常规护理。我们将在12个月时收集主要结局， 但我们也将收集3个月和24个月的结果，以评估一段时间内的趋势。我们将使用定量和 评估执行障碍的定性方法，包括全面的预算影响分析。 下一步/实施：如果有效，我们将与我们的业务合作伙伴，国家中心， 健康促进和预防（NCP），将D-ELITE整合到NCP的减肥产品中。的 国家肺/睡眠项目办公室也同意促进支持全国采用的政策。