Novel Data Collection and Analytics Tools for Remote Patient Monitoring in Heart Failure (Nov-RPM-HF) Trial: Rationale of Trial Design (Preprint)
UNSTRUCTURED Heart Failure (HF) remains a leading cause of mortality, and a major driver of healthcare utilization. Effective outpatient management requires the ability to identify and manage impending HF decompensation. Remote patient monitoring (RPM) aims to further address this current need in HF care. To date, RPM approaches employing noninvasive, home-based patient sensors have failed to demonstrate clinical efficacy. The Novel Data Collection and Analytics Tools for Remote Patient Monitoring in Heart Failure Trial (Nov-RPM-HF) aims to address current noninvasive RPM limitations. Nov-RPM-HF will evaluate a clinician-codesigned RPM platform employing emerging data collection and presentation tools. These tools include: (1) a ballistocardiograph to monitor nocturnal patient biometrics, such as heart and respiratory rate, (2) clinical alerts for abnormal biometrics, and (3) longitudinal data presentation for clinician review. Nov-RPM-HF is a 100-patient single-center prospective trial, evaluating patients over 6 months. Outcomes will include: (1) patient adherence to data collection, (2) patient/clinician-perceived utility of the RPM platform, (3) medication changes- including the titration of guideline-directed medical therapy to target doses, (4) HF symptoms/performance status, and (5) unplanned HF hospitalizations or emergency department visits. The results will help to inform the role of noninvasive RPM as a viable clinical management strategy in HF care.