Home monitoring with IT-supported specialist management versus home monitoring alone in patients with heart failure: Design and baseline results of the SUPPORT-HF 2 randomized trial

OBJECTIVES: SUPPORT-HF 2 tests the hypothesis that home monitoring with information technology-supported specialist management is more effective in optimizing medical therapy than is home monitoring alone for patients with heart failure. METHODS AND RESULTS: The study was designed as a 2-armed partially blinded parallel randomized controlled trial. Seven sites in the United Kingdom (UK) recruited a total of 202 adults with heart failure at high risk of adverse outcomes and with potential to benefit from remote management (mean age 73 years, 28% female, median left ventricular ejection fraction 37%). Both arms are given a home monitoring and communication kit (Internet-enabled tablet computer, Bluetooth-enabled blood pressure and heart rate monitor, and weighing scale). For each participant, an individualized plan for treatment of heart failure and major comorbidities is developed before randomization. Participants randomized to intervention receive regular feedback to support self-management, and their physicians receive advice on blood investigations and pharmacological treatment from a central specialist heart failure team. Participants in the control arm use the same monitoring system but with no central medical management support. The primary outcome is the use of recommended medical therapy, defined as treatment consistent with the guidelines for management of patients with chronic heart failure, and will be measured as a composite opportunity score. The trial data collection ended in October 2017, and results will be reported in 2019. TRIAL REGISTRATION: ISRCTN86212709. CONCLUSIONS: Preliminary experience suggests that central provision of tailored specialist management using commercially available low-cost monitoring and computing devices, enhanced by customized applications, is feasible.