RT Journal Article
SR Electronic
T1 Home telemonitoring study for Japanese patients with heart failure (HOMES-HF): protocol for a multicentre randomised controlled trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e002972
DO 10.1136/bmjopen-2013-002972
VO 3
IS 6
A1 Norihiko Kotooka
A1 Machiko Asaka
A1 Yasunori Sato
A1 Yoshiharu Kinugasa
A1 Kotaro Nochioka
A1 Atsushi Mizuno
A1 Daisuke Nagatomo
A1 Daigo Mine
A1 Yoko Yamada
A1 Kazuo Eguchi
A1 Hideki Hanaoka
A1 Takayuki Inomata
A1 Yoshihiro Fukumoto
A1 Kazuhiro Yamamoto
A1 Hiroyuki Tsutsui
A1 Tohru Masuyama
A1 Masafumi Kitakaze
A1 Teruo Inoue
A1 Hiroaki Shimokawa
A1 Shin-ichi Momomura
A1 Yoshihiko Seino
A1 Koichi Node
A1 on behalf of the HOMES-HF study investigators
YR 2013
UL http://bmjopen.bmj.com/content/3/6/e002972.abstract
AB Introduction 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. 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).