The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF)
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Home telemonitoring is becoming more important to home medical care for patients with heart failure. Since there are no data on home telemonitoring for Japanese patients with heart failure, we investigated its effect on cardiovascular outcomes. The HOMES-HF study was the first multicenter, open-label, randomized, controlled trial (RCT) to elucidate the effectiveness of home telemonitoring of physiological data, such as body weight, blood pressure, and pulse rate, for Japanese patients with heart failure (UMIN Clinical Trials Registry 000006839). The primary end-point was a composite of all-cause death or rehospitalization due to worsening heart failure. We analyzed 181 recently hospitalized patients with heart failure who were randomly assigned to a telemonitoring group (n = 90) or a usual care group (n = 91). The mean follow-up period was 15 (range 0–31) months. There was no statistically significant difference in the primary end-point between groups [hazard ratio (HR), 0.95; 95% confidence interval (CI), 0.548–1.648; p = 0.572]. Home telemonitoring for Japanese patients with heart failure was feasible; however, beneficial effects in addition to those of usual care were not demonstrated. Further investigation of more patients with severe heart failure, participation of home medical care providers, and use of a more integrated home telemonitoring system emphasizing communication as well as monitoring of symptoms and physiological data are required.
KeywordsHeart failure Disease management Telemonitoring Home healthcare Multidisciplinary
The authors gratefully acknowledge Tomoko Hirotaki, Miki Mori, Aya Yamada, Sae Katafuchi, and Junko Ishida for their valuable assistance. The members of HOMES-HF study investigators are Telemonitoring Center: Mika Nakamizo Chika Nishiyama, Kikumi Morita (Saga University). Independent Data Management Center: Yuko Horiuchi, Michiko Hanawa, Takako Kanai, and Hideki Hanaoka (Chiba University Hospital Clinical Research Center). Independent Endpoint Committee: Tohru Izumi (Kitasato University), Yoshihiko Saito (Nara Medical University), Yukihito Sato (Hyogo Prefectural Amagasaki Hospital). Local Investigators: Dokkyo Medical University Hospital, Tochigi (Haruyama A, Inami S, Nishi Y, Amano A, Arikawa T, Kikuchi M), Eto Clinic, Saga (Eto Y), Hiramatsu Hospital, Saga (Ishii K, Fukuda K, Soejima S), Hisano Clinic, Saga (Hisano R), Hokkaido University Hospital, Hokkaido (Goto D, Kinugawa S), Hyogo College of Medicine Hospital, Hyogo (Naito Y, Goda A, Iwasaku T, Eguchi A, Okuhara Y), Hyogo Prefectural Amagasaki Hospital, Hyogo (Taniguchi R, Takatsu Y, Washida K, Miyamoto T, Toma M, Yoshitani K, Fukuhara R, Fujiwara H), Imari Arita Kyoritsu Hospital, Saga (Matsunaga K), Jichi Medical University Hospital, Tochigi (Iwata T, Nishimura Y, Hoshide S, Shinpo M, Kario K), Katsuya Clinic, Hyogo (Katsuya T, Katsuya S), Kitasato University School of Medicine, Kanagawa (Naruke T, Kiryu M, Kurokawa S, Sato T, Koitabashi T), Koga Hospital 21, Fukuoka (Kajiwara M, Hiramatsu Y), Kyushu Kosei Nenkin Hospital, Fukuoka (Sedutsu Y, Hashimoto T, Yamamoto U, Miyata K, Mohri M, Yamamoto H, Origuchi H), National Cerebral and Cardiovascular Center Hospital, Osaka (Hasegawa T, Funada A, Takahama H, Ohara T, Kanzaki H, Asakura M, Noguchi T, Goto Y, Anzai T), Nippon Medical School Chiba-Hokusoh Hospital, Chiba (Ibuki C, Oba T, Takano M, Mitsunori Maruyama, Junko Abe, Daisuke Murakami, Ryo Munakata, Toru Inami, Nakamichi Kimata, Yamamoto T, Kurihara O), Oita University Hospital, Oita (Hara M, Nakagawa M, Yufu K, Sinohara T, Takahashi N, Saikawa T), Saga Prefectural Hospital Koseikan, Saga (Okahara A, Shirahama N, Koga Y, Nagamoto Y, Shiomi T, Yoshida K, Sadamatsu K), Saga University Hospital, Saga (Yoshioka G, Kakimoto Y, Uchino M, Tago M, Hiwatashi A, Kodama K, Sakamoto Y, Shimomura M, Sakuma M, Komatsu A, Yohisda K, Hikichi Y), Saiseikai Fukuoka General Hospital, Fukuoka (Hongo T, Natsuaki M), Saiseikai Karatsu Hospital, Saga (Sato A, Yazawa M, Tokushima T), Saitama Medical Center Jichi Medical University, Saitama (Hirahara T), Shimane University Hospital, Shimane (Watanabe N, Tanabe K, Ishibashi Y, Takahashi N, Endo A, Sugamori T, Kotani N, Sato H, Takeda M, Adachi T, Ito S, Ito S, Oshima T, Kawahara H, Paku M), St. Luke’s International Hospital, Tokyo (Nishi Y, Yamazoe M, Komatsu I, Niwa K), Tarumizu Municipal Medical Center, Tarumizu Chuo Hospital, Kagoshima (Iwatani N, Yamasuji K, Fukumoto N, Takenaka T, Abe S), Toho University Ohashi Medical Center, Tokyo (Noro M, Kujime S, Ito N, Enomoto Y), Tohoku University Hospital, Miyagi (Fukuda K, Takahashi J, Wakayama Y, Sugimura K, Matsumoto Y, Fukumoto Y), Tottori University Hospital, Tottori (Yanagihara K, Yamada K, Hirai M, Kato M).
Study conception and design: NK, KK, TI, KS, KY, HT, TM, HS, SM, YS, YS, TI, and KN. Conducting the trial and acquisition of data: YK, KN, AM, DN, DM, MA, YY, AK, NO, DF, SK, ST, SH, TK, and KE. Statistical analysis: KN and YS. Drafting the article: NK, MA, KN, and YS. Revising the article: MK, TI, KN, SH, KN, KY, HT, YS, and KN. Final approval: all authors.
The HOMES-HF study was supported by grants from the Japanese Ministry of Health, Labor, and Welfare Comprehensive Research on Aging and Health (KR23000003, KR24000001), and the Japan Society for the Promotion of Science KAKENHI Grant Number JP17K09510.
Compliance with ethical standards
Conflict of interest
Dr. Kotooka and Dr. Asaka have an endowed chair from Sumitomo Electric Industries Ltd., since 2014, and from Asahi Kasei Corporation since 2017. None of the authors has any relationship with industry or any financial associations within the past 2 years that might pose a conflict of interest in connection with the submitted article.
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