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