Home telemonitoring study for Japanese patients with heart failure (HOMES-HF): Protocol for a multicentre randomised controlled trial

Norihiko Kotooka, Machiko Asaka, Yasunori Sato, Yoshiharu Kinugasa, Kotaro Nochioka, Atsushi Mizuno, Daisuke Nagatomo, Daigo Mine, Yoko Yamada, Kazuo Eguchi, Hideki Hanaoka, Takayuki Inomata, Yoshihiro Fukumoto, Kazuhiro Yamamoto, Hiroyuki Tsutsui, Tohru Masuyama, Masafumi Kitakaze, Teruo Inoue, Hiroaki Shimokawa, Shin Ichi MomomuraYoshihiko Seino, Koichi Node

研究成果: Contribution to journalArticle査読

12 被引用数 (Scopus)

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Introduction: Despite the encouraging results from several randomised controlled trials (RCTs) and metaanalyses, the ability of home telemonitoring for heart failure (HF) to improve patient outcomes remains controversial as a consequence of the two recent largescale 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. Methods and analysis: 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. Trial Registration: The study is registered at UMIN Clinical Trials Registry (UMIN000006839).

本文言語英語
論文番号e002972
ジャーナルBMJ open
3
6
DOI
出版ステータス出版済み - 2013
外部発表はい

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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