Rationale and design of the Japanese heart failure outpatients disease management and cardiac evaluation (J-HOMECARE)
Miyuki Tsuchihashi-Makaya, Hisashi Matsuo, Shigeo Kakinoki, Shigeru Takechi, Hiroyuki Tsutsui, J-HOMECARE Investigators, Hiroyuki Tsutsui, Miyuki Tsuchihashi-Makaya, Takayuki Inomata, Shintaro Kinugawa, Kenichi Sugioka, Mayumi Koasa, Hisashi Kai, Tomomi Ide, Erina Ninomiya, Hisashi Matsuo, Toru Kaji, Yoshiko Nishino, Reiko Omi, Noboru Asai, Mizue Takahashi, Shigeo Kakinoki, Kazuhiko Nagai, Miki Takeuchi, Shuko Uchionbou, Shigeru Takechi, Atsuko Namikoshi, Masumi Sakurada, Masumi Furuya, Yuki Heishi, Miyuki Tsuchihashi-Makaya, Hisashi Matsuo, Shigeo Kakinoki, Shigeru Takechi, Hiroyuki Tsutsui, J-HOMECARE Investigators, Hiroyuki Tsutsui, Miyuki Tsuchihashi-Makaya, Takayuki Inomata, Shintaro Kinugawa, Kenichi Sugioka, Mayumi Koasa, Hisashi Kai, Tomomi Ide, Erina Ninomiya, Hisashi Matsuo, Toru Kaji, Yoshiko Nishino, Reiko Omi, Noboru Asai, Mizue Takahashi, Shigeo Kakinoki, Kazuhiko Nagai, Miki Takeuchi, Shuko Uchionbou, Shigeru Takechi, Atsuko Namikoshi, Masumi Sakurada, Masumi Furuya, Yuki Heishi
Abstract
Background: Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (QOL), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management. In addition, very little information is available on the effectiveness of disease management programs in other areas than the USA and Europe.
Methods: The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE) is a randomized controlled trial in which 156 patients hospitalized with HF will be randomized into usual care or a home-based disease management arm receiving comprehensive advice and counseling by visiting nurses during the initial 2 months and telephone follow-up for the following 4 months after discharge. This study evaluates depression and anxiety (Hospital Anxiety and Depression Scale), mortality, readmission due to HF, and QOL (Short Form-8). Data are collected during index hospitalization and then 2, 6, and 12 months after discharge. This study started in December 2007, and the final results are expected in 2011.
Conclusion: The J-HOMECARE will provide important information on the efficacy of disease management for psychological status as well as the effective components of disease management for patients with HF. (ClinicalTrials.gov number, NCT01284400).
Copyright © 2011 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Source: PubMed