The Novel Data Collection and Analytics Tools for Remote Patient Monitoring in Heart Failure (Nov-RPM-HF) Trial: Protocol for a Single-Center Prospective Trial.

The Novel Data Collection and Analytics Tools for Remote Patient Monitoring in Heart Failure (Nov-RPM-HF) Trial: Protocol for a Single-Center Prospective Trial.
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用于心力衰竭患者远程监测的新型数据收集和分析工具(Nov-RPM-HF)试验:单中心前瞻性试验方案。

DOI:
10.2196/32873
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发表时间:
2022-06-30
影响因子:
1.7
通讯作者:
--
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其他
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心力衰竭仍然是死亡的主要原因,也是医疗保健利用的主要驱动力。尽管心力衰竭方面的医学取得了许多进展,但相关的住院治疗仍在继续增加,这主要是由于门诊管理不佳。远程患者监护(RPM)旨在通过向临床团队提供数据,以先发制人地解决临床失代偿问题,进一步满足当前心力衰竭护理的这一需求。然而,迄今为止,RPM方法使用非侵入性的家庭为基础的患者传感器未能证明临床疗效。用于心力衰竭患者远程监测的新型数据收集和分析工具(Nov-RPM-HF)试验旨在解决当前无创RPM的局限性。Nov-RPM-HF将使用新兴的数据收集和呈现工具评估临床医生共同设计的RPM平台,用于心力衰竭管理。这些工具包括心冲击描记器,用于监测夜间患者生物特征,异常生物特征的临床警报,以及供临床医生审查的纵向数据显示。Nov-RPM-HF是一项100例患者的单中心前瞻性试验,对患者进行了6个月的评估。结局将包括患者对数据收集的依从性、患者/临床医生感知的RPM平台效用、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/体能状态以及计划外心力衰竭住院或急诊科访视。这项前瞻性试验于2020年3月开始招募,预计将于2022年6月完成招募,并于2022年12月完成试验。本试验方案旨在为心力衰竭RPM策略的评价提供一个系统的框架,这些策略目前被大量使用,但很少进行稳健的研究。试验结果将有助于告知非侵入性RPM作为心力衰竭护理中可行的临床管理策略的作用。DERR1-10.2196/32873
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. DERR1-10.2196/32873
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