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.

摘要 心力衰竭（HF）是住院治疗的最常见的主要诊断之一，也是心脏病的主要原因。 死亡在美国。据估计，高达65%的HF住院治疗是以下原因的结果： HF自我护理不足。尽管有明确证据表明HF自我护理可以降低死亡和住院风险 再次入院时，许多HF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HF症状，并进行体力活动。现有HF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 大量的提供者时间，并且由于社会经济限制，患者并不总是能够获得， 地理障碍和其他障碍。迫切需要可获得和可扩展的干预措施， 旨在帮助HF患者在社区中进行自我护理。消费者移动的健康（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 干预交付。然而，它们的功效在很大程度上仍有待探索。为了解决这个问题，我们的团队 开发了一种以患者为中心的HF自我护理干预（iCardia 4 HF），结合使用三种 市售的移动的健康应用程序和连接的健康设备（MyApps）， 针对可改变的行为因素的个性化定制短信（Text 4 HF），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NIH资助的随机对照试验， 试验（RCT）旨在测试iCardia 4 HF干预3个月的可行性和初步疗效 主要是少数民族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 重要可行性和初步数据。我们研究计划的下一步和目的是 拟议的研究是进行一项完全把握度的2x2析因RCT，以确定独立和合并的 两种iCardia 4 HF干预组件（MyApps和Text 4 HF）在6个月时的疗效，以及它们的 干预后6个月维持疗效。共360例依从性不佳的HF患者， 将招募HF自我护理者，并随机分配至四种条件之一，持续12个月：（1）家庭护理，（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 心血管住院或因任何原因死亡。次要结局是HF自我评估的客观指标。 护理依从性（药物治疗[MEMS]、每日称重和BP监测[Withings量表和BP监测仪]、低- 钠饮食[尿钠]和体力活动[加速度计]）、自我报告的HF自我护理、HRQL和 主要心脏事件（死亡、住院、ER访视）。这项研究将提供重要的新知识 这将决定性地塑造我们对商业化移动医疗技术潜力的理解， 并定制TM以改善HF自我护理依从性并减少HF患者的再入院。