iCardia4HF: A multi-component mHealth app and tailored text-messaging intervention to promote self-care adherence and improve outcomes in patients with chronic heart failure

摘要 心力衰竭(HF)是最常见的住院主要诊断之一，也是 美国的死亡案例。据估计，高达65%的心力衰竭住院是由于 高频自理能力不足。尽管有明确的证据表明心力衰竭自我护理可降低死亡率和住院风险 再入院期间，许多心力衰竭患者难以按处方服药，维持低钠饮食， 每天监测他们的体重和心力衰竭症状，并进行体力活动。现有的高频自理服务 面对面或通过电话提供的干预措施的影响和覆盖范围有限，因为它们需要 巨大的提供者时间，并且由于社会经济限制，患者并不总是能够接触到， 地理上的障碍，以及其他障碍。迫切需要可访问和可扩展的干预措施 旨在帮助心力衰竭患者在社区中进行自我护理。消费者移动健康(MHealth) 技术(例如，应用程序和传感器设备)有望促进HF自我护理和扩展 干预性交付。然而，它们的功效在很大程度上仍然没有得到充分的研究。为了解决这一差距，我们的团队 开发了一种以患者为中心的心力衰竭自我护理干预(IMedica4HF)，它结合了三种方法的使用 商业化的移动健康应用程序和联网健康设备(MyApp)，计划为 针对可修改的行为因素的个性化短信(Text4HF)，以促进HF自我护理 坚持并改善临床结果。我们最近完成了一项由美国国立卫生研究院资助的随机对照试验 试验(RCT)，以测试为期3个月的iMedica4HF干预的可行性和初步疗效 主要是少数族裔和社会经济上处于不利地位的HF人口。这项研究的结果提供 重要的可行性和初步数据。我们研究计划的下一步和 建议的研究是进行完全有效的2x2析因随机对照试验，以确定独立和合并的 两种iMedica4HF干预成分(MyApps和Text4HF)在6个月的疗效以及他们的 干预后6个月维持疗效。共有360名心衰患者依从性不佳 HF自我护理将被招募，并随机分为四种情况之一，为期12个月：(1)常规护理，(2) Text4HF、(3)MyApps或(4)MyApps&Text4HF。主要结果是因以下原因而损失的天数百分比 心血管疾病住院或因任何原因死亡。二次结局是心力衰竭自身的客观测量 护理依从性(用药[MEMS]、每日称重和血压监测[Withing Scale和BP监护仪]、低 钠饮食[尿钠]和体力活动[加速计])，自我报告的心力衰竭自我护理，HRQL，和 重大心脏事件(死亡率、住院、急诊室就诊)。这项研究将提供重要的新知识 这将极大地影响我们对商业化移动健康技术潜力的理解 并量身定做TMS，以提高心力衰竭患者的自我护理依从性，并减少心力衰竭患者的再次住院。

Abstract Heart failure (HF) is one of the most frequent principal diagnoses for hospitalization and a leading cause of death in the United States. It has been estimated that up to 65% of HF hospitalizations are the results of insufficient HF self-care. Despite clear evidence that HF self-care reduces the risk of mortality and hospital readmissions, many HF patients struggle to take medications as prescribed, maintain a low sodium diet, monitor their weight and HF symptoms daily, and engage in physical activity. Existing HF self-care interventions delivered face-to-face or via telephone have had limited impact and reach because they require significant provider time and are not always accessible to patients due to socioeconomic constraints, geographic barriers, and other obstacles. There is a critical need for accessible and scalable interventions that are designed to assist patients with HF self-care while in the community. Consumer mobile health (mHealth) technologies (e.g., apps and sensor devices) hold promise for promoting HF self-care and expanding intervention delivery. However, their efficacy remains largely underexplored. To address this gap, our team developed a patient-centered HF self-care intervention (iCardia4HF) that combines the use of three commercially available mobile health apps and connected health devices (MyApps) with a program of individually tailored text messages (Text4HF) targeting modifiable behavioral factors to promote HF self-care adherence and improve clinical outcomes. We recently completed a NIH-funded pilot randomized controlled trial (RCT) to test the feasibility and preliminary efficacy of the iCardia4HF intervention over 3 months in a predominantly minority and socioeconomically disadvantaged HF population. Results from this study provide important feasibility and preliminary data. The next step in our program of research and purpose of the proposed study is to conduct a fully powered, 2x2 factorial RCT to determine the independent and combined efficacy of the two iCardia4HF intervention components (MyApps and Text4HF) at 6 months, as well as their maintenance efficacy at 6 months post-intervention. A total of 360 HF patients with suboptimal adherence to HF self-care will be recruited and randomized to one of four conditions for 12 months: (1) Usual care, (2) Text4HF, (3) MyApps, or (4) MyApps&Text4HF. The primary outcome is percent of days lost due to cardiovascular hospitalization or death for any cause. Secondary outcomes are objective measures of HF self- care adherence (medication [MEMS], daily weighing and BP monitoring [Withings scale and BP monitor], low- sodium diet [urinary sodium], and physical activity [accelerometer]), self-reported HF self-care, HRQL, and major cardiac events (mortality, hospitalizations, ER visits). This study will provide important new knowledge that will critically shape our understanding about the potential of commercially available mHealth technologies and tailored TMs to improve HF self-care adherence and reduce hospital readmissions in patients with HF.