A novel behavioral intervention to promote adherence in heart failure

心力衰竭(HF)影响着近600万美国人，并导致严重的功能障碍， 生活质量和生存。健康行为(例如，体育活动、低钠饮食、药物) 与心力衰竭患者的健康改善相关，包括存活率，但大多数心力衰竭患者没有足够的坚持 这些行为。现有的健康行为计划对依从性和心脏疾病的影响有限 结果，许多患者无法获得，并且不针对独立相关的心理因素 心脏健康。基于激励面试(MI)的项目已被证明可以提高参与度 但可能不足以改善心力衰竭患者的下游健康结局。 积极心理学(PP)，它利用系统的活动(例如，利用优势，表达 感恩)培养幸福感，可能是HF健康行为计划的重要组成部分。正性 心理结构与两种健康行为的一致性具有前瞻性和独立性的关系 和改善心血管健康，PP干预已被证明改善了这些结构和 提高心血管疾病患者或有心血管疾病风险的患者的健康行为依从性。此外，PP 可以与MI相结合，以促进自我效能、动机和从事健康行为的意图。 我们最近完成了一个多阶段项目(Reach For Health)，以开发一种为期12周的电话- 提供积极心理-动机访谈(PP-MI)联合干预以促进身体健康 心衰患者的活动、饮食和用药依从性。我们现在的目标是检查这一计划的有效性， 每周额外发送两次PP和健康行为短信，总计24周，而MI- 基于教育对照条件，在NIH第二阶段，对280名纽约患者进行随机临床试验 心脏协会I-III级心衰和对体力活动、饮食或药物的次佳坚持。这个 主要研究结果将是客观测量的健康行为依从性(综合结果)的变化 中等到剧烈的体力活动[通过加速计测量]，钠摄入量[24小时尿钠]， 和药物依从性[药物事件监测系统电子药瓶])，我们假设 PP-MI与基于MI的教育条件相比，将导致更大程度的遵从性改进。 我们还将衡量干预对心理健康、生活质量、功能结果、 心血管健康的标记物(例如，体重指数、血脂、血糖)和主要不良心脏事件。 我们将利用我们团队在临床试验、心脏病学以及基于PP和MI的干预方面的专业知识来 根据PA-18-722的目标，有效和高效地执行拟议的试验，目的是 “测试[一种]创新方法…用于维护个人的…坚持复杂的医疗保健方案。如果 为了有效，我们将在一项更大的试验中检查干预对心血管健康结果的影响，并将 开始探索在临床环境中实施这种潜在的高度可扩展的干预措施的方法。

Heart failure (HF) affects nearly 6 million Americans and leads to significant impairments in functioning, quality of life, and survival. Health behaviors (e.g., physical activity, low-sodium diet, medications) are associated with improved health, including survival, in HF, but most HF patients do not adhere adequately to these behaviors. Existing health behavior programs have had limited impact on adherence and cardiac outcomes, are inaccessible to many patients, and do not target psychological factors independently associated with heart health. Motivational interviewing- (MI-) based programs have been shown to increase engagement in HF self-care behaviors but may not be sufficient to improve downstream health outcomes in HF patients. Positive psychology (PP), which utilizes systematic activities (e.g., using strengths, expressing gratitude) to cultivate well-being, may be an important component of a health behavior program in HF. Positive psychological constructs are prospectively and independently associated with both health behavior adherence and improved cardiovascular health, and PP interventions have been shown to improve these constructs and increase health behavior adherence in patients with or at risk for cardiovascular disease. Furthermore, PP could be combined with MI to promote self-efficacy, motivation, and intention to engage in health behaviors. We recently completed a multi-stage project (REACH for Health) to develop a 12-week, telephone- delivered, combined positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity, diet, and medication adherence in HF. We now aim to examine the efficacy of this program, with additional twice weekly PP and health behavior text messages for a total of 24 weeks, compared to an MI- based educational control condition, in an NIH Stage II, randomized clinical trial in 280 patients with New York Heart Association class I-III HF and suboptimal adherence to physical activity, diet, or medications. The primary study outcome will be change in objectively measured health behavior adherence (composite outcome of moderate to vigorous physical activity [measured via accelerometer], sodium intake [24h urinary sodium], and medication adherence [Medication Event Monitoring System electronic pill bottle]), and we hypothesize that PP-MI will lead to greater improvements in adherence compared to the MI-based educational condition. We also will measure the intervention’s impact on psychological health, quality of life, functional outcomes, markers of cardiovascular health (e.g., body mass index, lipids, glucose), and major adverse cardiac events. We will utilize our team’s expertise in clinical trials, cardiology, and PP- and MI-based interventions to effectively and efficiently perform the proposed trial, which—consistent with the goals of PA-18-722—aims to “test [an] innovative approach…for maintaining individuals’…adherence to complex health care regimens.” If effective, we will examine the intervention’s effects on cardiovascular health outcomes in a larger trial and will begin to explore ways to implement this potentially highly scalable intervention in clinical settings.