TY - JOUR
T1 - The Novel Data Collection and Analytics Tools for Remote Patient Monitoring in Heart Failure (Nov-RPM-HF) Trial
T2 - Protocol for a Single-Center Prospective Trial
AU - Bhatia, Ankit
AU - Ewald, Gregory
AU - Maddox, Thomas
N1 - Funding Information:
TM discloses current grant funding from the National Institutes of Health National Center for Advancing Translational Sciences (1U24TR002306-01: A National Center for Digital Health Informatics Innovation); current consulting for Creative Educational Concepts, Inc and Atheneum Partners; and honoraria or expense reimbursement in the past 3 years from the University of Utah (May 2017), New York Presbyterian (Sept 2017), Westchester Medical Center (Oct 2017), Sentara Heart Hospital (Dec 2018), the Henry Ford health system (March 2019), and the University of California San Diego (Jan 2020). He is currently employed as a cardiologist and the executive director of the Healthcare Innovation Lab at BJC HealthCare/Washington University School of Medicine. In this capacity, he is advising Myia Labs, for which his employer is receiving equity compensation in the company. He is receiving no individual compensation from the company. He is also a compensated director for a New Mexico–based foundation, the JF Maddox Foundation.
Publisher Copyright:
© Ankit Bhatia, Gregory Ewald, Thomas Maddox.
PY - 2022/6/1
Y1 - 2022/6/1
N2 - Background: Heart failure remains a leading cause of mortality and a major driver of health care utilization. Despite numerous medical advances in heart failure, associated hospitalizations continue to increase, owing largely to suboptimal outpatient management. Remote patient monitoring (RPM) aims to further address this current need in heart failure care by providing data to clinical teams to act pre-emptively to address clinical decompensation. However, to date, RPM approaches using noninvasive home-based patient sensors have failed to demonstrate clinical efficacy. Objective: The Novel Data Collection and Analytics Tools for Remote Patient Monitoring in Heart Failure (Nov-RPM-HF) Trial aims to address current noninvasive RPM limitations. Nov-RPM-HF will evaluate a clinician co-designed RPM platform using emerging data collection and presentation tools for heart failure management. These tools include a ballistocardiograph to monitor nocturnal patient biometrics, clinical alerts for abnormal biometrics, and longitudinal data presentation for clinician review. Methods: Nov-RPM-HF is a 100-patient single-center prospective trial, evaluating patients over 6 months. The outcomes will include patient adherence to data collection, patient/clinician-perceived utility of the RPM platform, medication changes including the titration of guideline-directed medical therapy to target doses, heart failure symptoms/performance status, and unplanned heart failure hospitalizations or emergency department visits. Results: This prospective trial began enrollment in March 2020 and anticipates enrollment completion by June 2022, with trial completion by December 2022. Conclusions: This trial protocol aims to provide a systematic framework for the evaluation of heart failure RPM strategies, which are currently heavily used but seldom robustly studied. The trial results will help to inform the role of noninvasive RPM as a viable clinical management strategy in heart failure care.
AB - Background: Heart failure remains a leading cause of mortality and a major driver of health care utilization. Despite numerous medical advances in heart failure, associated hospitalizations continue to increase, owing largely to suboptimal outpatient management. Remote patient monitoring (RPM) aims to further address this current need in heart failure care by providing data to clinical teams to act pre-emptively to address clinical decompensation. However, to date, RPM approaches using noninvasive home-based patient sensors have failed to demonstrate clinical efficacy. Objective: The Novel Data Collection and Analytics Tools for Remote Patient Monitoring in Heart Failure (Nov-RPM-HF) Trial aims to address current noninvasive RPM limitations. Nov-RPM-HF will evaluate a clinician co-designed RPM platform using emerging data collection and presentation tools for heart failure management. These tools include a ballistocardiograph to monitor nocturnal patient biometrics, clinical alerts for abnormal biometrics, and longitudinal data presentation for clinician review. Methods: Nov-RPM-HF is a 100-patient single-center prospective trial, evaluating patients over 6 months. The outcomes will include patient adherence to data collection, patient/clinician-perceived utility of the RPM platform, medication changes including the titration of guideline-directed medical therapy to target doses, heart failure symptoms/performance status, and unplanned heart failure hospitalizations or emergency department visits. Results: This prospective trial began enrollment in March 2020 and anticipates enrollment completion by June 2022, with trial completion by December 2022. Conclusions: This trial protocol aims to provide a systematic framework for the evaluation of heart failure RPM strategies, which are currently heavily used but seldom robustly studied. The trial results will help to inform the role of noninvasive RPM as a viable clinical management strategy in heart failure care.
KW - cardiology
KW - clinical innovation
KW - digital health
KW - heart failure
KW - mHealth
KW - mobile health
KW - remote patient monitoring
UR - http://www.scopus.com/inward/record.url?scp=85134381692&partnerID=8YFLogxK
U2 - 10.2196/32873
DO - 10.2196/32873
M3 - Article
C2 - 35771609
AN - SCOPUS:85134381692
SN - 1929-0748
VL - 11
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 6
M1 - e32873
ER -