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）是住院治疗中最常见的主要诊断之一，也是导致患者死亡的主要原因。 在美国死亡。据估计，高达 65% 的心力衰竭住院治疗是由于 高频自我护理不足。尽管有明确的证据表明心力衰竭自我护理可降低死亡和住院风险 再入院，许多心力衰竭患者很难按处方服用药物，维持低钠饮食， 每天监测体重和心力衰竭症状，并进行体育活动。现有的高频自我护理 面对面或通过电话提供的干预措施的影响和范围有限，因为它们需要 由于社会经济的限制，提供者需要花费大量的时间，并且患者并不总是能够获得服务， 地理障碍和其他障碍。迫切需要可及且可扩展的干预措施 旨在帮助心力衰竭患者在社区进行自我护理。消费者移动健康（mHealth） 技术（例如应用程序和传感器设备）有望促进高频自我护理和扩大 干预实施。然而，它们的功效在很大程度上仍未得到充分探索。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措施 (iCardia4HF)，结合使用三种方法 商用移动健康应用程序和连接的健康设备 (MyApps) 以及以下程序 针对可修改行为因素的个性化短信 (Text4HF)，以促进心力衰竭自我护理 坚持并改善临床结果。我们最近完成了一项由 NIH 资助的试点随机对照试验 试验 (RCT)，旨在测试 iCardia4HF 干预措施在 3 个月内的可行性和初步疗效 主要是少数民族和社会经济弱势的高频人口。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目的 拟议的研究是进行全动力、2x2 阶乘 RCT 以确定独立和组合 两种 iCardia4HF 干预组件（MyApps 和 Text4HF）在 6 个月时的功效及其 干预后 6 个月维持疗效。共有 360 名 HF 患者依从性不佳 将招募心力衰竭自我护理人员并随机分配到以下四种情况之一，为期 12 个月：(1) 常规护理，(2) Text4HF、(3) MyApps 或 (4) MyApps&Text4HF。主要结果是由于以下原因损失的天数百分比 心血管疾病住院或因任何原因死亡。次要结果是 HF 自我的客观测量 护理依从性（药物 [MEMS]、每日称重和血压监测 [Withings 体重秤和血压监测仪]、低 钠饮食 [尿钠] 和体力活动 [加速度计]）、自我报告的心力衰竭自我护理、HRQL 和 主要心脏事件（死亡、住院、急诊室就诊）。这项研究将提供重要的新知识 这将至关重要地影响我们对商用移动医疗技术潜力的理解 并定制TM以提高心力衰竭自我护理依从性并减少心力衰竭患者的再入院率。