Intelligent Hypertension Intervention Study

Study Overview
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Brief Summary
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To explore whether the application of intelligent hypertension management system can effectively reduce blood pressure in hypertensive patients. A total of 320 eligible subjects will be recruited and randomization to two groups. The standard care group (n=160) will receive conventional hypertension treatment with baseline data collected.Wearable blood pressure monitoring device management group (intervention group, n=160) will receive blood pressure monitoring remotely everyday and antihypertension medication treatment. Primary outcome is Net change in systolic blood pressure from baseline to 3 months follow-up. Secondary outcomes include Net change in diastolic blood pressure hypertension control ratio (BP < 140/90 mmHg)

Official Title
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Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System

Conditions
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To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients

Intervention / Treatment
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* Device: Intelligent Hypertension Management System
* Other: The standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged more than 18 years old, less than or equal to 75 years old. Hypertensive patients (systolic/diastolic blood pressure ≥140/90 mmHg at two separate screening/baseline visits) Patients or guardians can skillfully use devices such as smartphones and electronic sphygmomanometers Voluntarily joined and signed the informed consent Exclusion Criteria: Pregnant women or women planning to become pregnant within the next year; Patients with secondary hypertension Patients with life expectancy less than 1 year Severe hepatic and renal insufficiency (ALT > 5 times ULA, eGFR < 15ml/min/1.73mm2) Known active malignancy disease The researcher believes that patients who are not suitable to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The standard care group<br> | Other: The standard care<br>* The standard care<br>|
| Experimental: Intelligent intervention group<br> | Device: Intelligent Hypertension Management System<br>* The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net change in systolic blood pressure from baseline to 3 months follow-up |  | one and three months after study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net change in diastolic blood pressure |  | one and three months after study | 
| Hypertension control ratio (BP < 140/90 mmHg) |  | one and three months after study |