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Effect of intelligent hypertension management system on blood pressure: protocol for a randomised controlled
Haiyang Yu1, Xiang Chen2, Jiachun Xia2
1Department of cardiology, Shanghai Songjiang District Central Hospital, Songjiang, Shanghai, China.
Insights
This study evaluated an Intelligent Hypertension Management System (IHMS) for hypertension control. The IHMS aims to help patients self-monitor blood pressure at home, potentially improving hypertension management.
Area of Science:
- Cardiovascular Medicine
- Health Informatics
- Digital Health
Background:
- Hypertension is a major global health concern with suboptimal control rates in China.
- Lifestyle interventions and medication are primary treatments, but new strategies are needed.
- Self-monitoring of blood pressure offers a promising approach for improved hypertension management.
Purpose of the Study:
- To investigate the effectiveness of the Intelligent Hypertension Management System (IHMS) in reducing blood pressure among hypertensive patients.
- To assess if IHMS facilitates intelligent hypertension management through remote monitoring and guidance.
Main Methods:
- A multi-center, prospective, randomized controlled study involving 320 eligible subjects.
- Participants were randomized into an IHMS management group (n=160) and a conventional care group (n=160).
- The primary outcome was the net change in systolic blood pressure after 3 months, analyzed using a mixed-effects model.
Main Results:
- The study aims to determine if the IHMS group exhibits a greater reduction in systolic blood pressure compared to the conventional care group.
- Analysis will focus on the primary outcome measure at the 3-month follow-up.
- The mixed-effects model will be employed for robust statistical comparison.
Conclusions:
- The findings will elucidate the efficacy of the IHMS in improving blood pressure control.
- Results will inform the potential integration of digital health platforms in hypertension management strategies.
- Dissemination of findings is planned through publications and conference presentations.
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.
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