Department of Cardiovascular Medicine, Saga University, Saga, Japan.
BMJ Open. 2013 Jun 20;3(6):e002972. doi: 10.1136/bmjopen-2013-002972.
Despite the encouraging results from several randomised controlled trials (RCTs) and meta-analyses, the ability of home telemonitoring for heart failure (HF) to improve patient outcomes remains controversial as a consequence of the two recent large-scale RCTs. However, it has been suggested that there is a subgroup of patients with HF who may benefit from telemonitoring. The aim of the present study was to investigate whether an HF management programme using telemonitoring could improve outcomes in patients with HF under the Japanese healthcare system.
The Home Telemonitoring Study for Japanese Patients with Heart Failure (HOMES-HF) study is a prospective, multicentre RCT to investigate the effectiveness of home telemonitoring on the primary composite endpoint of all-cause death and rehospitalisation due to worsening HF in recently admitted HF patients (aged 20 and older, New York Heart Association classes II-III). The telemonitoring system is an automated physiological monitoring system including body weight, blood pressure and pulse rate by full-time nurses 7 days a week. Additionally, the system was designed to make it a high priority to support patient's self-care instead of an early detection of HF decompensation. A total sample size of 420 patients is planned according to the Schoenfeld and Richter method. Eligible patients are randomly assigned via a website to either the telemonitoring group or the usual care group by using a minimisation method with biased-coin assignment balancing on age, left ventricular ejection fraction and a history of ischaemic heart disease. Participants will be enrolled until August 2013 and followed until August 2014. Time to events will be estimated using the Kaplan-Meier method, and HRs and 95% CIs will be calculated using the Cox proportional hazards models with stratification factors.
The study is registered at UMIN Clinical Trials Registry (UMIN000006839).
尽管几项随机对照试验（RCT）和荟萃分析的结果令人鼓舞，但由于最近两项大型 RCT，家庭远程心力衰竭（HF）监测改善患者结局的能力仍然存在争议。然而，有人认为，有一部分 HF 患者可能受益于远程监测。本研究旨在探讨使用远程监测的 HF 管理方案是否可以改善日本医疗保健系统下 HF 患者的结局。
家庭远程监测心力衰竭日本患者研究（HOMES-HF）是一项前瞻性、多中心 RCT，旨在研究家庭远程监测对近期入院 HF 患者（年龄 20 岁及以上，纽约心脏协会分级 II-III）全因死亡和因 HF 恶化再住院的主要复合终点的有效性。远程监测系统是一种自动化生理监测系统，包括 7 天/周由全职护士进行的体重、血压和脉搏率监测。此外，该系统旨在将支持患者的自我护理作为首要任务，而不是早期发现 HF 失代偿。根据 Schoenfeld 和 Richter 方法，计划总样本量为 420 例患者。通过网站使用偏向硬币分配的最小化方法，根据年龄、左心室射血分数和缺血性心脏病史对患者进行随机分组，将符合条件的患者分配到远程监测组或常规护理组。参与者将被招募到 2013 年 8 月，随访到 2014 年 8 月。使用 Kaplan-Meier 方法估计时间事件，使用 Cox 比例风险模型和分层因素计算 HR 和 95%CI。
该研究在 UMIN 临床试验注册处（UMIN000006839）注册。
