Bhatia Ankit, Ewald Gregory, Maddox Thomas
Division of Cardiology, Washington University School of Medicine, Saint Louis, MO, United States.
Healthcare Innovation Lab, BJC Healthcare, Washington University School of Medicine, Saint Louis, MO, United States.
JMIR Res Protoc. 2022 Jun 30;11(6):e32873. doi: 10.2196/32873.
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.
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.
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.
This prospective trial began enrollment in March 2020 and anticipates enrollment completion by June 2022, with trial completion by December 2022.
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.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32873.
心力衰竭仍然是主要的死亡原因，也是医疗保健利用的主要驱动因素。尽管心力衰竭在医学上取得了诸多进展，但相关住院率仍在持续上升，这在很大程度上归因于门诊管理欠佳。远程患者监测（RPM）旨在通过向临床团队提供数据，以便预先采取行动应对临床失代偿，从而进一步满足当前心力衰竭护理的需求。然而，迄今为止，使用基于家庭的非侵入性患者传感器的RPM方法尚未证明其临床疗效。
心力衰竭远程患者监测新型数据收集与分析工具（Nov-RPM-HF）试验旨在解决当前非侵入性RPM的局限性。Nov-RPM-HF将使用用于心力衰竭管理的新兴数据收集和呈现工具，评估临床医生共同设计的RPM平台。这些工具包括用于监测夜间患者生物特征的心冲击图、生物特征异常的临床警报以及供临床医生审查的纵向数据呈现。
Nov-RPM-HF是一项纳入100名患者的单中心前瞻性试验，对患者进行6个月的评估。结果将包括患者对数据收集的依从性、患者/临床医生对RPM平台的感知效用、药物变化（包括将指南指导的药物治疗滴定至目标剂量）、心力衰竭症状/功能状态以及非计划的心力衰竭住院或急诊就诊。
这项前瞻性试验于2020年3月开始招募，预计2022年6月完成招募，并于2022年12月完成试验。
本试验方案旨在为评估心力衰竭RPM策略提供一个系统框架，目前这些策略被大量使用，但很少得到充分研究。试验结果将有助于明确非侵入性RPM在心力衰竭护理中作为一种可行的临床管理策略的作用。
国际注册报告识别码（IRRID）：DERR1-10.2196/32873
