A novel behavioral intervention to promote adherence in heart failure

心力衰竭（HF）影响近600万美国人，并导致功能的严重损害， 生活质量和生存。健康行为（例如，体力活动，低钠饮食，药物）是 与HF患者的健康状况改善（包括生存率）相关，但大多数HF患者不能充分遵守 这些行为。现有的健康行为计划对依从性和心脏病的影响有限。 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。动机性面试-（MI-）为基础的程序已被证明可以提高参与度 HF自我护理行为，但可能不足以改善HF患者的下游健康结果。 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。积极 心理结构与健康行为依从性和健康行为依从性 和改善心血管健康，PP干预已被证明可以改善这些结构， 提高心血管疾病患者或有心血管疾病风险患者的健康行为依从性。此外，PP 可以与MI相结合，以促进自我效能感，动机和意图从事健康行为。 我们最近完成了一个多阶段项目（REACH for Health），开发了一个为期12周的电话- 提供，结合积极的心理动机访谈（PP-MI）干预，以促进身体 HF患者的活动、饮食和药物依从性。我们现在的目标是检查该计划的有效性， 每周两次额外的PP和健康行为短信，共24周，与MI相比， 基于教育控制条件，在NIH第二阶段，随机临床试验中，280例患者纽约 心脏协会I-III级HF和对体力活动、饮食或药物的依从性欠佳。的 主要研究结果将是客观测量的健康行为依从性的变化（复合结果 中度至剧烈体力活动[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将导致更大的改善，坚持相比，MI为基础的教育条件。 我们还将衡量干预对心理健康、生活质量、功能结果的影响， 心血管健康的标志物（例如，体重指数、脂质、葡萄糖）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， 有效且高效地执行拟议的试验，该试验与PA-18-722的目标一致，旨在 “测试[一种]创新方法......以维持个人......坚持复杂的医疗保健方案。”如果 有效，我们将在一个更大的试验中检查干预对心血管健康结果的影响， 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.