Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 12;13(12):e074580.
doi: 10.1136/bmjopen-2023-074580.

Effect of intelligent hypertension management system on blood pressure: protocol for a randomised controlled multicentre trial

Haiyang Yu #  1 , Xiang Chen #  2 , Jiachun Xia  2 , Lei Hou  3   2
Affiliations

Effect of intelligent hypertension management system on blood pressure: protocol for a randomised controlled multicentre trial

Haiyang Yu et al. BMJ Open. .

Abstract

Introduction: Hypertension is one of the most serious global health problems, and its prevention and treatment mainly rely on lifestyle intervention and medication. However, the current situation of hypertension control in China is still not ideal. Self-monitoring of blood pressure is expected to be a new way to control hypertension. Intervention and the Intelligent Hypertension Management System (IHMS), an information platform relying on the network and smartphone, may help patients self-monitor their blood pressure at home, allowing for intelligent management of hypertension. The aim of this trial is to investigate whether IHMS can effectively reduce blood pressure in patients with hypertension.

Methods and analysis: This is a multiple-centre, prospective, randomised, controlled study. 320 eligible subjects will be randomly divided into the IHMS management group (n=160) and the conventional care group (n=160). Subjects in the IHMS management group will be required to take their blood pressure daily at regular intervals at home and get treatment as directed by the IHMS; the control group will receive conventional treatment. The primary outcome of the trial is the net change in systolic blood pressure at the end point of follow-up after 3 months. The mixed-effects model will be used to compare the primary outcome that there is a greater reduction in blood pressure in the intervention group than in the control group.

Ethics and dissemination: The Ethics Committee of Shanghai Tongren Hospital has reviewed and approved the trial protocols, informed consent and subject information. The findings from the study will be disseminated through publications and conference presentations. The findings of the trial will be published in journals and presented at academic conferences.

Trial registration number: NCT05526300.

Keywords: Blood Pressure; Clinical Trial; Hypertension.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors and members of various organisations have no conflicts of interest. On behalf of all authors, the corresponding author states that there is no conflict of interest.

Figures

Figure 1
Figure 1
Study design of the trial. IHMS, Intelligent Hypertension Management System.
See this image and copyright information in PMC

References

    1. 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. 10.1001/jama.2017.11358 - DOI - PMC - PubMed
    1. Whelton PK, He J, Appel LJ, et al. Primary prevention of hypertension: clinical and public health advisory from the National high blood pressure education program. JAMA 2002;288:1882–8. 10.1001/jama.288.15.1882 - DOI - PubMed
    1. Thomopoulos C, Parati G, Zanchetti A. Effects of blood pressure-lowering treatment on cardiovascular outcomes and mortality: 14 - effects of different classes of antihypertensive drugs in older and younger patients: overview and meta-analysis. J Hypertens 2018;36:1637–47. 10.1097/HJH.0000000000001777 - DOI - PubMed
    1. Bundy JD, Li C, Stuchlik P, et al. Systolic blood pressure reduction and risk of cardiovascular disease and mortality: A systematic review and network meta-analysis. JAMA Cardiol 2017;2:775–81. 10.1001/jamacardio.2017.1421 - DOI - PMC - PubMed
    1. SPRINT Research Group, Wright JT, Williamson JD, et al. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med 2015;373:2103–16. 10.1056/NEJMoa1511939 - DOI - PMC - PubMed

Publication types

Associated data