Korean Circulation Journal

The Korean Society of Cardiology (대한심장학회)
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Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial

  • Dong-Ju Choi (Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital) ;
  • Jin Joo Park (Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital) ;
  • Minjae Yoon (Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital) ;
  • Sung-Ji Park (Division of Cardiology, Heart Vascular Stroke Institute, Samsung Medical Center/Sungkyunkwan University School of Medicine) ;
  • Sang-Ho Jo (Division of Cardiology, Hallym University Sacred Heart Hospital/Hallym University College of Medicine) ;
  • Eung Ju Kim (Cardiovascular Center, Korea University Guro Hospital) ;
  • Soo-Joong Kim (Division of Cardiology, Kyung Hee University Hospital) ;
  • Sungyoung Lee (Department of Computer Science and Engineering, Kyung Hee University)
  • Received : 2022.05.05
  • Accepted : 2022.08.16
  • Published : 2022.10.01
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Abstract

Background and Objectives: Self-monitoring of blood pressure (SMBP) is a reliable method used to assess BP accurately. However, patients do not often know how to respond to the measured BP value. We developed a mobile application-based feed-back algorithm (SMBP-App) for tailored recommendations. In this study, we aim to evaluate whether SMBP-App is superior to SMBP alone in terms of BP reduction and drug adherence improvement in patients with hypertension. Methods: Self-Monitoring of blood pressure and Feed-back using APP in Treatment of UnconTrolled Hypertension (SMART-BP) is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App compared with SMBP alone. Patients with uncomplicated essential hypertension will be randomly assigned to the SMBP-App (90 patients) and SMBP alone (90 patients) groups. In the SMBP group, the patients will perform home BP measurement and receive the standard care, whereas in the SMBP-App group, the patients will receive additional recommendations from the application in response to the obtained BP value. Follow-up visits will be scheduled at 12 and 24 weeks after randomization. The primary endpoint of the study is the mean home systolic BP. The secondary endpoints include the drug adherence, the home diastolic BP, home and office BP. Conclusions: SMART-BP is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App. If we can confirm its efficacy, SMBP-App may be scaled-up to improve the treatment of hypertension.

Keywords

Acknowledgement

We thank the MD Research Co. for the electronic case report form and data management.

References

  1. Lewington S, Clarke R, Qizilbash N, et al. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-13.
  2. Park JK, Lim YH, Kim KS, et al. Changes in body fat distribution through menopause increase blood pressure independently of total body fat in middle-aged women: the Korean National Health and Nutrition Examination Survey 2007-2010. Hypertens Res 2013;36:444-9.
  3. Correction to: heart disease and stroke statistics-2017 update: a report from the American Heart Association. Circulation 2017;136:e196.
  4. Adler AI, Stratton IM, Neil HA, et al. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ 2000;321:412-9.
  5. Wright JT Jr, Williamson JD, Whelton PK, et al. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med 2015;373:2103-16.
  6. Hajjar I, Kotchen TA. Trends in prevalence, awareness, treatment, and control of hypertension in the United States, 1988-2000. JAMA 2003;290:199-206.
  7. Nieuwlaat R, Wilczynski N, Navarro T, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2014;(11):CD000011.
  8. Fletcher BR, Hartmann-Boyce J, Hinton L, McManus RJ. The effect of self-monitoring of blood pressure on medication adherence and lifestyle factors: a systematic review and meta-analysis. Am J Hypertens 2015;28:1209-21.
  9. Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension global hypertension practice guidelines. J Hypertens 2020;38:982-1004.
  10. Tucker KL, Sheppard JP, Stevens R, et al. Self-monitoring of blood pressure in hypertension: a systematic review and individual patient data meta-analysis. PLoS Med 2017;14:e1002389.
  11. Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit 2015;20:164-7.
  12. Rinfret S, Lussier MT, Peirce A, et al. The impact of a multidisciplinary information technology-supported program on blood pressure control in primary care. Circ Cardiovasc Qual Outcomes 2009;2:170-7.
  13. He J, Irazola V, Mills KT, et al. Effect of a community health worker-led multicomponent intervention on blood pressure control in low-income patients in argentina: a randomized clinical trial. JAMA 2017;318:1016-25.
  14. Lim SS, Vos T, Flaxman AD, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2224-60.
  15. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321:405-12.
  16. Chobanian AV, Bakris GL, Black HR, et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003;289:2560-72.
  17. Neal B, MacMahon S, Chapman N; Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Lancet 2000;356:1955-64.
  18. Psaty BM, Smith NL, Siscovick DS, et al. Health outcomes associated with antihypertensive therapies used as first-line agents. A systematic review and meta-analysis. JAMA 1997;277:739-45.
  19. Ogedegbe G, Schoenthaler A. A systematic review of the effects of home blood pressure monitoring on medication adherence. J Clin Hypertens (Greenwich) 2006;8:174-80.
  20. Morawski K, Ghazinouri R, Krumme A, et al. Association of a smartphone application with medication adherence and blood pressure control: the MedISAFE-BP randomized clinical trial. JAMA Intern Med 2018;178:802-9.
  21. Moore JO, Marshall MA, Judge D, et al. Technology-supported apprenticeship in the management of hypertension: a randomized controlled trial. J Clin Outcomes Manag 2014;21:110-22.
  22. Choi DJ, Park JJ, Ali T, Lee S. Artificial intelligence for the diagnosis of heart failure. NPJ Digit Med 2020;3:54.
  23. Park JJ, Lee CJ, Park SJ, et al. Heart failure statistics in Korea, 2020: a report from the Korean Society of Heart Failure. Int J Heart Fail 2021;3:224.