Advertisement

Heart and Vessels

, Volume 33, Issue 8, pp 866–876 | Cite as

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)

  • Norihiko Kotooka
  • Masafumi Kitakaze
  • Kengo Nagashima
  • Machiko Asaka
  • Yoshiharu Kinugasa
  • Kotaro Nochioka
  • Atsushi Mizuno
  • Daisuke Nagatomo
  • Daigo Mine
  • Yoko Yamada
  • Akiko Kuratomi
  • Norihiro Okada
  • Daisuke Fujimatsu
  • So Kuwahata
  • Shigeru Toyoda
  • Shin-ichi Hirotani
  • Takahiro Komori
  • Kazuo Eguchi
  • Kazuomi Kario
  • Takayuki Inomata
  • Kaoru Sugi
  • Kazuhiro Yamamoto
  • Hiroyuki Tsutsui
  • Tohru Masuyama
  • Hiroaki Shimokawa
  • Shin-ichi Momomura
  • Yoshihiko Seino
  • Yasunori Sato
  • Teruo Inoue
  • Koichi Node
  • On behalf of the HOMES-HF study investigators
Original Article
  • 287 Downloads

Abstract

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.

Keywords

Heart failure Disease management Telemonitoring Home healthcare Multidisciplinary 

Notes

Acknowledgements

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).

Author contributions

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.

Funding

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.

References

  1. 1.
    Okura Y, Ramadan MM, Ohno Y, Mitsuma W, Tanaka K, Ito M, Suzuki K, Tanabe N, Kodama M, Aizawa Y (2008) Impending epidemic future-projection of heart failure in Japan to the year 2055. Circ J 72:489–491CrossRefPubMedGoogle Scholar
  2. 2.
    Pandor A, Gomersall T, Stevens JW, Wang J, Al-Mohammad A, Bakhai A, Cleland JGF, Cowie MR, Wong R (2013) Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis. Heart 99:1717–1726CrossRefPubMedGoogle Scholar
  3. 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. 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. 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. 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
  7. 7.
    Brown S, Thorpe H, Hawkins K, Brown J (2005) Minimization–reducing predictability for multi-centre trials whilst retaining balance within centre. Stat Med 24:3715–3727CrossRefPubMedGoogle Scholar
  8. 8.
    Folstein MF, Folstein SE, McHugh PR (1975) Mini-mental state: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12:189–198CrossRefPubMedGoogle Scholar
  9. 9.
    Sakano Y, Tojyo M (1986) The General Self-Efficacy Scale (GSES): scale development and validation. Jap J Behav Ther 12:73–82Google Scholar
  10. 10.
    Rector TS (2005) A conceptual model of quality of life in relation to heart failure. J Card Fail 11:173–176CrossRefPubMedGoogle Scholar
  11. 11.
    Kroenke K, Spitzer RL, Williams JB (2001) The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 16:606–613CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Chaudhry SI, Phillips CO, Stewart SS, Riegel B, Mattera JA, Jerant AF, Krumholz HM (2007) Telemonitoring for patients with chronic heart failure: a systematic review. J Card Fail 13:56–62CrossRefPubMedPubMedCentralGoogle Scholar
  13. 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
  14. 14.
    Schoenfeld DA, Richter JR (1982) Nomograms for calculating the number of patients needed for a clinical trial with survival as an endpoint. Biometrics 38:163–170CrossRefPubMedGoogle Scholar
  15. 15.
    Gooley TA, Leisenring W, Crowley J, Storer BE (1999) Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Stat Med 18:695–706CrossRefPubMedGoogle Scholar
  16. 16.
    Fine JP, Gray RJ (1999) A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 94:496–509CrossRefGoogle Scholar
  17. 17.
    Bakoyannis G, Touloumi G (2012) Practical methods for competing risks data: a review. Stat Methods Med Res 21:257–272CrossRefPubMedGoogle Scholar
  18. 18.
    Satagopan JM, Ben-Porat L, Berwick M, Robson M, Kutler D, Auerbach AD (2004) A note on competing risks in survival data analysis. Br J Cancer 91:1229–1235CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Whellan DJ, Hasselblad V, Peterson E, O’Connor CM, Schulman KA (2005) Meta-analysis and review of heart failure disease management randomized controlled clinical trials. Am Heart J 149:722–729CrossRefPubMedGoogle Scholar
  20. 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
  21. 21.
    Swedberg K, Wolf A, Ekman I (2011) Telemonitoring in patients with heart failure. N Engl J Med 364:1078 (author reply 1079–1080) CrossRefPubMedGoogle Scholar
  22. 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
  23. 23.
    Charlson ME, Pompei P, Ales KL, MacKenzie CR (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 40:373–383CrossRefPubMedGoogle Scholar
  24. 24.
    Tsuchihashi M, Tsutsui H, Kodama K, Kasagi F, Takeshita A (2000) Clinical characteristics and prognosis of hospitalized patients with congestive heart failure, a study in Fukuoka, Japan. Jpn Circ J 64:953–959CrossRefPubMedGoogle Scholar
  25. 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
  26. 26.
    DeBusk RF, Miller NH, Parker KM, Bandura A, Kraemer HC, Cher DJ, West JA, Fowler MB, Greenwald G (2004) Care management for low-risk patients with heart failure: a randomized, controlled trial. Ann Intern Med 141:606–613CrossRefPubMedGoogle Scholar
  27. 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
  28. 28.
    Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM (1995) A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med 333:1190–1195CrossRefPubMedGoogle Scholar
  29. 29.
    Kahan BC, Cro S, Doré CJ, Bratton DJ, Rehal S, Maskell NA, Rahman N, Jairath V (2014) Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials. Trials 15:456CrossRefPubMedPubMedCentralGoogle Scholar
  30. 30.
    Frenneaux MP, Gollop ND, Loudon BL, Parasuraman S (2015) Remote monitoring in heart failure. Eur Heart J Qual Care Clin Outcomes 1:45–46CrossRefPubMedGoogle Scholar

Copyright information

© Springer Japan KK, part of Springer Nature 2018

Authors and Affiliations

  • Norihiko Kotooka
    • 1
  • Masafumi Kitakaze
    • 2
  • Kengo Nagashima
    • 3
  • Machiko Asaka
    • 1
  • Yoshiharu Kinugasa
    • 4
  • Kotaro Nochioka
    • 5
  • Atsushi Mizuno
    • 6
  • Daisuke Nagatomo
    • 1
  • Daigo Mine
    • 1
  • Yoko Yamada
    • 7
  • Akiko Kuratomi
    • 8
  • Norihiro Okada
    • 9
  • Daisuke Fujimatsu
    • 10
  • So Kuwahata
    • 11
  • Shigeru Toyoda
    • 12
  • Shin-ichi Hirotani
    • 13
  • Takahiro Komori
    • 14
  • Kazuo Eguchi
    • 14
  • Kazuomi Kario
    • 14
  • Takayuki Inomata
    • 15
  • Kaoru Sugi
    • 16
  • Kazuhiro Yamamoto
    • 4
  • Hiroyuki Tsutsui
    • 17
  • Tohru Masuyama
    • 13
  • Hiroaki Shimokawa
    • 5
  • Shin-ichi Momomura
    • 7
  • Yoshihiko Seino
    • 18
  • Yasunori Sato
    • 3
  • Teruo Inoue
    • 12
  • Koichi Node
    • 1
  • On behalf of the HOMES-HF study investigators
  1. 1.Department of Cardiovascular MedicineSaga UniversitySagaJapan
  2. 2.Department of Clinical Medicine and DevelopmentNational Cerebral and Cardiovascular CenterSuitaJapan
  3. 3.Department of Clinical Research, Graduate School of MedicineChiba UniversityChibaJapan
  4. 4.Division of Cardiovascular Medicine, Department of Molecular Medicine and TherapeuticsTottori UniversityYonagoJapan
  5. 5.Department of Cardiovascular MedicineTohoku University Graduate School of MedicineSendaiJapan
  6. 6.Department of CardiologySt. Luke’s International HospitalTokyoJapan
  7. 7.Division of Cardiovascular Medicine, Saitama Medical CenterJichi Medical UniversityOmiyaJapan
  8. 8.Koga Hospital 21KurumeJapan
  9. 9.Department of Cardiology and Clinical ExaminationOita UniversityOitaJapan
  10. 10.Saiseikai Karatsu HospitalKaratsuJapan
  11. 11.Tarumizu Municipal Medical Center, Tarumizu Chuo HospitalTarumizuJapan
  12. 12.Department of Cardiovascular MedicineDokkyo Medical UniversityMibuJapan
  13. 13.Cardiovascular Division, Department of Internal MedicineHyogo College of MedicineNishinomiyaJapan
  14. 14.Department of Medicine, Division of Cardiovascular MedicineJichi Medical UniversityShimotsukeJapan
  15. 15.Department of Cardiovascular MedicineKitasato Institute HospitalTokyoJapan
  16. 16.Toho University Ohashi Medical CenterTokyoJapan
  17. 17.Department of Cardiovascular MedicineHokkaido University Graduate School of MedicineSapporoJapan
  18. 18.Department of CardiologyNippon Medical School Chiba-Hokusoh HospitalInzaiJapan

Personalised recommendations