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)
- 287 Downloads
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.
- 3.Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, and Krumholz HM (2010) Telemonitoring in patients with heart failure. N Engl J Med 363:2301–2309 (Erratum in: (2013) N Engl J Med 369:1869. (2011) N Engl J Med 364:490)Google Scholar
- 4.Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD, On behalf of the Telemedical Interventional Monitoring in Heart Failure Investigators (2011) Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation 123:1873–1880CrossRefPubMedGoogle Scholar
- 5.Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm M, Brouwer S, Perrin E, Baumann G, Gelbrich G, Boll H, Honold M, Koehler K, Kirwan BA, Anker SD (2012) Telemedicine in heart failure: pre-specified and exploratory subgroup analyses from the TIM-HF trial. Int J Cardiol 29:143–150CrossRefGoogle Scholar
- 6.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 S, Seino Y, Node K, On behalf of the HOMES-HF study investigators (2013) Home telemonitoring study for Japanese patients with heart failure (HOMES-HF): protocol for a multicentre randomised controlled trial. BMJ Open 3(6):e002972CrossRefPubMedPubMedCentralGoogle Scholar
- 9.Sakano Y, Tojyo M (1986) The General Self-Efficacy Scale (GSES): scale development and validation. Jap J Behav Ther 12:73–82Google Scholar
- 13.Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A (2009) A meta-analysis of remote monitoring of heart failure patients. J Am Coll Cardiol 54:1683–1694 (Erratum in: (2010) J Am Coll Cardiol 55:2185)Google Scholar
- 20.Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JG (2011) Which components of heart failure programmes are effective? A systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: a bridged cochrane review. Eur J Heart Fail 13:1028–1040CrossRefPubMedGoogle Scholar
- 22.Walsh MN, Bove AA, Cross RR, Ferdinand KC, Forman DE, Freeman AM, Hughes S, Klodas E, Koplan M, Lewis WR, MacDonnell B, May DC, Messer JV, Pressler SJ, Sanz ML, Spertus JA, Spinler SA, Teichholz LE, Wong JB, Byrd KD, Drozda JP, Cacchione JG, Erb BD, Harrington RA, Kennett JD, Krumholz HM, Masoudi FA, Peterson ED, Poppas A, Sahn DJ, Sanz ML, Shahian DM, Windle JR, Wyman JF (2012) American College of Cardiology Foundation. ACCF 2012 health policy statement on patient-centered care in cardiovascular medicine: a report of the American College of Cardiology Foundation Clinical Quality Committee. J Am Coll Cardiol 59:2125–2143CrossRefPubMedGoogle Scholar
- 25.Tsuchihashi-Makaya M, Hamaguchi S, Kinugawa S, Yokota T, Goto D, Yokoshiki H, Kato N, Takeshita A, Tsutsui H, For the JCARE-CARD Investigators (2009) Characteristics and outcomes of hospitalized patients with heart failure and reduced vs preserved ejection fraction. Report from the Japanese Cardiac Registry of Heart Failure in Cardiology (JCARE-CARD). Circ J 73:1893–1900 (Erratum in: (2009) Circ J 73:2365)Google Scholar
- 27.Goldberg LR, Piette JD, Walsh MN, Frank TA, Jaski BE, Smith AL, Rodriguez R, Mancini DM, Hopton LA, Orav EJ, Loh E, On behalf of the WHARF Investigators (2003) Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial. Am Heart J 146:705–712CrossRefPubMedGoogle Scholar