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 Momomura & 2 others Yoshihiko Seino, Koichi Node

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

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).

Original languageEnglish
Article numbere002972
JournalBMJ open
Volume3
Issue number6
DOIs
Publication statusPublished - 2013 Jun 13
Externally publishedYes

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Randomized Controlled Trials
Heart Failure
Numismatics
Physiologic Monitoring
Self Care
Proportional Hazards Models
Stroke Volume
Sample Size
Myocardial Ischemia
Registries
Cause of Death
Patient Care
Heart Rate
Body Weight
Clinical Trials
Blood Pressure
Delivery of Health Care

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Home telemonitoring study for Japanese patients with heart failure (HOMES-HF) : Protocol for a multicentre randomised controlled trial. / Kotooka, Norihiko; Asaka, Machiko; Sato, Yasunori; Kinugasa, Yoshiharu; Nochioka, Kotaro; Mizuno, Atsushi; Nagatomo, Daisuke; Mine, Daigo; Yamada, Yoko; Eguchi, Kazuo; Hanaoka, Hideki; Inomata, Takayuki; Fukumoto, Yoshihiro; Yamamoto, Kazuhiro; Tsutsui, Hiroyuki; Masuyama, Tohru; Kitakaze, Masafumi; Inoue, Teruo; Shimokawa, Hiroaki; Momomura, Shin Ichi; Seino, Yoshihiko; Node, Koichi.

In: BMJ open, Vol. 3, No. 6, e002972, 13.06.2013.

Research output: Contribution to journalArticle

Kotooka, N, Asaka, M, Sato, Y, Kinugasa, Y, Nochioka, K, Mizuno, A, Nagatomo, D, Mine, D, Yamada, Y, Eguchi, K, Hanaoka, H, Inomata, T, Fukumoto, Y, Yamamoto, K, Tsutsui, H, Masuyama, T, Kitakaze, M, Inoue, T, Shimokawa, H, Momomura, SI, Seino, Y & Node, K 2013, 'Home telemonitoring study for Japanese patients with heart failure (HOMES-HF): Protocol for a multicentre randomised controlled trial', BMJ open, vol. 3, no. 6, e002972. https://doi.org/10.1136/bmjopen-2013-002972
Kotooka, Norihiko ; Asaka, Machiko ; Sato, Yasunori ; Kinugasa, Yoshiharu ; Nochioka, Kotaro ; Mizuno, Atsushi ; Nagatomo, Daisuke ; Mine, Daigo ; Yamada, Yoko ; Eguchi, Kazuo ; Hanaoka, Hideki ; Inomata, Takayuki ; Fukumoto, Yoshihiro ; Yamamoto, Kazuhiro ; Tsutsui, Hiroyuki ; Masuyama, Tohru ; Kitakaze, Masafumi ; Inoue, Teruo ; Shimokawa, Hiroaki ; Momomura, Shin Ichi ; Seino, Yoshihiko ; Node, Koichi. / Home telemonitoring study for Japanese patients with heart failure (HOMES-HF) : Protocol for a multicentre randomised controlled trial. In: BMJ open. 2013 ; Vol. 3, No. 6.
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AU - Sato, Yasunori

AU - Kinugasa, Yoshiharu

AU - Nochioka, Kotaro

AU - Mizuno, Atsushi

AU - Nagatomo, Daisuke

AU - Mine, Daigo

AU - Yamada, Yoko

AU - Eguchi, Kazuo

AU - Hanaoka, Hideki

AU - Inomata, Takayuki

AU - Fukumoto, Yoshihiro

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AU - Tsutsui, Hiroyuki

AU - Masuyama, Tohru

AU - Kitakaze, Masafumi

AU - Inoue, Teruo

AU - Shimokawa, Hiroaki

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AU - Seino, Yoshihiko

AU - Node, Koichi

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