Addressing insufficient positive airway pressure use among older Veterans with obstructive sleep apnea

解决患有阻塞性睡眠呼吸暂停的老年退伍军人气道正压使用不足的问题

• 批准号: 10427211
• 负责人: Cathy A Alessi
• 金额: --
• 依托单位: VA GREATER LOS ANGELES 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: 2021-07-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10427211
• 关键词: Address; Adverse effects; Aftercare; Area; Attitude; Behavior Therapy; Behavioral; COVID-19 pandemic; Cardiovascular Diseases; Caring; Chronic; Clinical; Data; Diabetes Mellitus; Diagnosis; Discipline; Disease; Drowsiness; Education; Elderly; Equipment; Goals; Health; Healthcare Systems; High Prevalence; Hour; Hypertension; Hypoxia; Impaired cognition; Individual; Information Systems; Institution; Intervention; Left; Manuals; Measurement; Measures; Mental Depression; Mental Health; Methodology; Modeling; Newly Diagnosed; Obstructive Sleep Apnea; Outcome; Outcome Measure; Participant; Patient Outcomes Assessments; Patients; Personal Satisfaction; Pittsburgh Sleep Quality Index; Prevalence; Provider; Psychologist; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Self Management; Services; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Structure; Supervision; Techniques; Telephone; Testing; Time; Treatment Efficacy; Veterans; Work; adverse outcome; aged; airway obstruction; attentional control; base; clinical practice; coronavirus disease; cost estimate; design; effective intervention; efficacy testing; experience; follow-up; functional outcomes; future implementation; health related quality of life; implementation outcomes; improved; innovation; interest; novel; novel strategies; outreach; physical conditioning; pilot test; positive airway pressure; primary outcome; programs; remote grading; remote health care; remote monitoring; remote therapy; sleep quality; stroke recovery; telehealth; telemonitoring; tool; treatment as usual; virtual

Background: The most frequently diagnosed sleep disorder among older Veterans is obstructive sleep apnea (OSA), which is associated with serious adverse effects on health, quality of life and survival. Positive airway pressure (PAP) is recommended as first-line treatment (particularly for moderate to severe OSA), but sustained use is difficult to achieve, including among older Veterans, and nearly half of patients with OSA who begin PAP therapy discontinue use within a year. Significance/Impact: Although OSA is a chronic condition, research to date has primarily focused on increasing initial PAP use in patients with newly diagnosed OSA. In addition, most research has not addressed PAP use in older adults, which is unfortunate given the high prevalence and important adverse effects of OSA on their health and well-being. Prior work suggests that behavioral interventions are effective in improving initial PAP use, but little is known of how to address insufficient use over time. Innovation: To address this problem, we developed and pilot-tested a structured, manual-based approach to address insufficient PAP use among older adults with previously diagnosed OSA. The intervention (5 sessions over 8 weeks, then monthly contact for up to 6 months) is designed so it can be provided by individuals (“sleep coaches”) from various disciplines (supervised remotely by a psychologist) in a variety of settings for maximal implementation. Core components of the intervention include: 1) educational and behavioral approaches to improve PAP use, 2) individualized self-management and troubleshooting techniques to address factors contributing to insufficient PAP use, and 3) ongoing review of objective PAP use (via remote monitoring). Specific Aims: Primary Aim 1 will test the efficacy of this intervention for improving PAP usage among older Veterans with previously diagnosed OSA who have insufficient PAP use. Our hypotheses are that the intervention will increase objectively measured PAP use at 6-months follow-up, with effects sustained at 12 months. Secondary Aim 2 will test for effects on sleep quality, daytime sleepiness and sleep-related function; and Exploratory Aim 3 will test for effects on health-related quality of life. Our hypotheses are that these outcomes will also improve at 6 months, and effects will be sustained at 12 months. Methodology: We propose a randomized, controlled trial to test this new intervention in older Veterans (aged > 65 years, N=90) with previously diagnosed OSA (moderate to severe) who were prescribed PAP 1-5 years in the past, but have insufficient PAP use (defined as no PAP use over the prior 30 days). Given prior growing interest in telehealth and remote monitoring approaches to optimize PAP use, and the ongoing COVID-19 pandemic, all aspects of the study will be performed virtually in keeping with the latest VA COVID-era guidance for the remote testing and treatment of OSA. Participants will be randomized to the intervention or a control program that mirrors “optimal usual care” for OSA plus general sleep education (attention control). Structured assessments at baseline, post-treatment (after session 5) and 6- and 12-months follow-up include objectively measured PAP use (via remote telemonitoring), sleep quality (Pittsburgh Sleep Quality Index), daytime sleepiness (Epworth Sleepiness Scale), sleep-related function (Functional Outcomes of Sleep-10) and health- related quality of life (PROMIS-29 v2.1 Physical and Mental Health Summary Scores). We will collect participant experiences and attitudes related to the intervention, and implementation outcome measures (acceptability, appropriateness, fidelity and staff time as an estimate of cost) to inform future implementation. Implementation/Next Steps: The long-term goal of this work is to effectively address insufficient PAP use among older Veterans with OSA to improve their health and quality of life. If successful, we will implement the intervention at our institution, and develop and disseminate an implementation package with actual tools needed to promote wider implementation of this model of care into clinical practice.

背景：在老年退伍军人中最常见的睡眠障碍是阻塞性睡眠呼吸暂停 (OSA)这与对健康、生活质量和生存的严重不良影响有关。气道正压 压力（PAP）被推荐为一线治疗（特别是对于中度至重度OSA），但 持续使用很难实现，包括老年退伍军人，近一半的OSA患者 开始PAP治疗，一年内停止使用。 意义/影响：虽然OSA是一种慢性疾病，但迄今为止的研究主要集中在增加 新诊断OSA患者的初始PAP使用。此外，大多数研究没有涉及PAP的使用 在老年人中，这是不幸的，因为OSA的高患病率和重要的不利影响， 健康和福祉。先前的工作表明，行为干预在改善初始PAP方面是有效的 使用，但很少有人知道如何解决随着时间的推移使用不足。 创新：为了解决这个问题，我们开发并试点测试了一种结构化的、基于手动的方法， 解决先前诊断为OSA的老年人中PAP使用不足的问题。干预（5次会议） 超过8周，然后每月接触长达6个月）的设计，使它可以由个人提供（“睡眠 教练”）从各种学科（由心理学家远程监督）在各种设置，以最大限度地 实施.干预的核心组成部分包括：1）教育和行为方法， 改善PAP使用，2）个体化自我管理和故障排除技术，以解决因素 导致PAP使用不足，以及3）持续审查客观PAP使用（通过远程监测）。 具体目标：主要目标1将测试这种干预措施在老年人中改善PAP使用的有效性。 以前诊断为OSA的退伍军人，PAP使用不足。我们的假设是 在6个月随访时，干预将增加客观测量的PAP使用，其效果持续至12 个月次要目标2将测试对睡眠质量、日间嗜睡和睡眠相关功能的影响; 探索性目标3将测试对健康相关生活质量的影响。我们的假设是 6个月时的结果也会改善，12个月时效果会持续。 方法：我们提出了一个随机对照试验，以测试这种新的干预措施在老年退伍军人（年龄> 65岁，N=90），既往诊断为OSA（中度至重度）， 过去，但PAP使用不足（定义为过去30天内未使用PAP）。给定先验增长 对远程医疗和远程监测方法的兴趣，以优化PAP的使用，以及正在进行的COVID-19 大流行，研究的所有方面都将按照VA COVID时代的最新指南进行 用于阻塞性睡眠呼吸暂停的远程检测和治疗参与者将被随机分配到干预组或对照组 反映OSA的“最佳常规护理”加上一般睡眠教育（注意力控制）的计划。结构化 基线、治疗后（第5次治疗后）以及6个月和12个月随访时的评估客观地包括 测量PAP使用（通过远程远程监测），睡眠质量（匹兹堡睡眠质量指数），白天 嗜睡（埃普沃思嗜睡量表）、睡眠相关功能（睡眠功能结局-10）和健康- 相关生活质量（PROMIS-29 v2.1身心健康总分）。我们将收集 参与者对干预措施的经验和态度，以及实施结果的测量 （可接受性、适当性、忠实性和工作人员时间作为费用估计数），以便为今后的执行工作提供信息。 实施/后续步骤：这项工作的长期目标是有效解决PAP使用不足的问题 为患有阻塞性睡眠呼吸暂停综合症的老年退伍军人提供帮助，以改善他们的健康和生活质量。如果成功，我们将实施 在我们机构进行干预，并制定和传播一套具有实际工具的执行方案 需要促进这种护理模式在临床实践中的更广泛实施。