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.
