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. 2022 Mar 30;12(3):e049162.
doi: 10.1136/bmjopen-2021-049162.

Simplified regimen for the management of hypertension with telemedicine and blood pressure self-monitoring (SIMPLE): study protocol for a randomised controlled trial

Yao Li #  1 , Rusitanmujiang Maimaitiaili #  2 , Yi Zhang  2 , Tienan Feng  3 , Yawei Xu  2 , Haotian Yang  2 , Ji Zhang  4 , Jia Shi  5 , Mingliang Wang  6 , Fang Zhao  6 , Junqing Gao  5 , Jun Hu  7 , Chenghua Jiang  1 , Yifan Zhao  8
Affiliations

Simplified regimen for the management of hypertension with telemedicine and blood pressure self-monitoring (SIMPLE): study protocol for a randomised controlled trial

Yao Li et al. BMJ Open. .

Abstract

Introduction: Telemedicine and blood pressure (BP) self-monitoring conduces to management of hypertension. Recent hypertension guidelines highly recommended single pill combination (SPC) for the initial treatment of essential hypertension. Based on this fact, an SPC-based telemedicine titration regimen with BP self-monitoring could be a better way in managing hypertension. This trial aims to elucidate whether telemedicine combined with BP self-monitoring is superior to self-monitoring alone during hypertension management.

Methods and analysis: This study will be a multicentred, open-labelled, randomised controlled trial. A minimum sample of 358 hypertensive patients with uncontrolled BP from four centres will be included. The intervention group will include BP self-monitoring and tele-monitoring plus a free SPC-based telemedicine titration therapy for 6 months, they will be recommended to take BP measurements at least once every 7 days, in the meantime, researchers will call to give a consultation on lifestyle or titration advice once a fortnight. The control group will be required to self-monitor BP at the same time interval as intervention group, without any therapy change. Primary outcome of the trial will be the difference in systolic blood pressure at 6-month follow-up between intervention and control group, adjusted for baseline variables. Secondary outcomes such as BP control rate, major adverse cardiovascular events, medication adherence, quality of life will be investigated.

Ethics and dissemination: Ethics approval was granted by Ethical Committee of Shanghai Tenth People's Hospital (SHSY-IEC-4.1/20-194/01). The results will be disseminated in peer-reviewed literature, and to policy-makers and healthcare partners.

Trial registration number: ChiCTR2000037217.

Keywords: adult cardiology; epidemiology; hypertension.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Schematic representation of the simple trial. During the screening phase, participants’ drug adherence will be fully evaluated. Participants who failed the screening will be directed to registered cohort. Participants who passed the screening will be stratified by centre during randomisation. There will be two office visits for all participants during run-in phase. Maximum duration of this trial will be 6 months. BP, blood pressure; HBP, home blood pressure.
Figure 2
Figure 2
Antihypertensives titration regimen of the simple trial. A+C SPC: ACEI +CCB SPC. T1: half dose of an SPC pill; T2: a full dose of SPC; T3: a full dose of SPC plus diuretic; T4: a full does of SPC plus diuretic plus MRA. ACEI, ACE inhibitor; HBP, home blood pressure; CCB, calcium channel blocker; MRA, mineralocorticoid receptor antagonist; SPC, single pill combination.
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References

    1. Patel P, Ordunez P, DiPette D, et al. . Improved blood pressure control to reduce cardiovascular disease morbidity and mortality: the standardized hypertension treatment and prevention project. J Clin Hypertens 2016;18:1284–94. 10.1111/jch.12861 - DOI - PMC - PubMed
    1. Lozano R, Naghavi M, Foreman K, et al. . Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the global burden of disease study 2010. Lancet 2012;380:2095–128. 10.1016/S0140-6736(12)61728-0 - DOI - PMC - PubMed
    1. Roth GA, Mensah GA, Johnson CO, et al. . Global burden of cardiovascular diseases and risk factors, 1990-2019: update from the GBD 2019 study. J Am Coll Cardiol 2020;76:2982-3021. 10.1016/j.jacc.2020.11.010 - DOI - PMC - PubMed
    1. NCD Risk Factor Collaboration (NCD-RisC) . Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19·1 million participants. Lancet 2017;389:37–55. 10.1016/S0140-6736(16)31919-5 - DOI - PMC - PubMed
    1. Wang Z, Chen Z, Zhang L, et al. . Status of hypertension in China: results from the China hypertension survey, 2012-2015. Circulation 2018;137:2344–56. 10.1161/CIRCULATIONAHA.117.032380 - DOI - PubMed

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