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

iCardia4HF：一款多组件移动医疗应用程序和定制短信干预，可促进慢性心力衰竭患者的自我护理依从性并改善预后

• 批准号: 10639357
• 负责人: Spyros Kitsiou
• 金额: $ 75.74万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-14 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10639357
• 关键词: Accelerometer; Address; Adherence; African American population; Age; Behavior; Behavioral; Blood Pressure Monitors; Cardiac; Cardiovascular system; Cause of Death; Cessation of life; Clinical; Communities; Congestive Heart Failure; Data; Death Rate; Devices; Diagnosis; Diet; Drug Prescriptions; Emergency department visit; Employment; Enrollment; Ethnic Origin; Event; Failure; Funding; Health; Health Care Costs; Health Services Accessibility; Health Technology; Health behavior; Heart failure; Home; Hospitalization; Hospitals; Income; Individual; Insurance; Intervention; Knowledge; Link; Maintenance; Measures; Mediating; Mental Depression; Minority; Mobile Health Application; Modeling; Monitor; Morbidity - disease rate; Outcome; Partner in relationship; Patient Readmission; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Physical activity; Population; Prevalence; Provider; Race; Randomized; Randomized, Controlled Trials; Recommendation; Research; Risk Reduction; Self Care; Self Efficacy; Shapes; Socioeconomic Factors; Sodium; Sodium-Restricted Diet; Symptoms; Technology; Telephone; Testing; Time; Treatment Efficacy; United States; United States National Institutes of Health; Urine; Weight; care seeking; comorbidity; connected health; digital health; expectation; feasibility testing; fitbit; geographic barrier; health belief; health related quality of life; healthy lifestyle; hospital readmission; improved; improved outcome; innovation; intervention delivery; intervention effect; mHealth; mortality; mortality risk; patient oriented; pilot test; post intervention; primary outcome; programs; recruit; secondary outcome; sensor; skills; socioeconomic disadvantage; socioeconomics; tailored text messaging; text messaging intervention; theories; therapy design; tool; treatment as usual; urinary

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.

抽象的 心力衰竭（HF）是住院的最常见主要诊断之一，也是主要原因 在美国死亡。据估计，多达65％的HF住院是 HF自我保健不足。尽管有明确的证据表明HF自我保健降低了死亡率和医院的风险 再入院，许多HF患者努力服用处方药，保持低钠饮食， 每天监测其体重和HF症状，并进行体育锻炼。现有的HF自我保健 面对面或通过电话进行的干预措施的影响力有限，因为它们需要 大量的提供者时间，由于社会经济的限制，患者并不总是可以使用的时间 地理障碍和其他障碍。对于可访问且可扩展的干预措施的迫切需要 旨在帮助社区中HF自我保健的患者。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自我保健和扩展 干预交付。但是，它们的功效在很大程度上仍然没有得到充实的效果。为了解决这个差距，我们的团队 开发了一个以患者为中心的HF自我护理干预（Icardia4HF） 商业上可用的移动健康应用程序和连接的健康设备（MyApps） 针对可修改的行为因素的单独量身定制的文本消息（Text4HF）来促进HF自我护理 依从性并改善临床结果。我们最近完成了NIH资助的飞行员随机控制 试验（RCT）在3个月内测试Icardia4HF干预的可行性和初步疗效 主要是少数群体和社会经济不利的HF人口。这项研究的结果提供了 重要的可行性和初步数据。我们的研究计划和目的计划的下一步 拟议的研究是进行完全动力的2x2阶乘RCT，以确定独立和组合 两个iCardia4HF干预组件（MyApps和Text4HF）的功效在6个月及其 干预后6个月的维护功效。共有360例次优遵守的HF患者 HF自我保健将被招募并随机分为12个月的四个条件之一：（1）通常的护理，（2） text4hf，（3）myApps或（4）myApps＆text4hf。主要结果是由于 任何原因的心血管住院或死亡。次要结果是HF自我的客观度量 护理依从性（药物[MEMS]，每日称重和BP监测[Withings Scale and BP Monitor]，低 - 钠饮食[尿钠]和体育锻炼[加速度计]），自我报告的HF自我护理，HRQL和 重大心脏事件（死亡率，住院，急诊就诊）。这项研究将提供重要的新知识 这将严重影响我们对市售MHealth技术潜力的理解 并量身定制的TMS以提高HF自我保健依从性并减少HF患者的医院再入院。