Remote Blood Pressure Management Clinical Application Research

Study Overview
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Brief Summary
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Recruit patients with essential hypertension and randomly divide them into three groups. For 24 months, observe the patient's blood pressure level and blood pressure compliance rate,Risk assessment, etc.

Detailed Description
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Recruit patients with essential hypertension and randomly divide them into three groups. One group through remote blood pressure management platform realizes functions such as automatic upload of patient measurement data, intelligent analysis, and early warning reminders;One group is distributed a set of electronic sphygmomanometers , and the blood pressure is recorded by themselves following routine community hypertension management; one group follows routine community hypertension management. For 24 months, observe the patient's blood pressure level and blood pressure compliance rate,Risk assessment, etc. The main technical difficulties and problems to be solved: Widely popularize remote blood pressure based on Cloud Sharing Smart Cabinet Management mode. Innovation point: Provide primary hospitals with an intelligent, simple and efficient innovative tool for the management of residents chronic diseases, and improve the management level of chronic diseases in my country promotly; adopt intelligent terminal equipment to realize automatic data collection and transmission to ensure patient real blood pressure data timely and continuously, providing data reference and basis for academic research and the prevention and treatment of chronic diseases, and promoting scientific research in the prevention and treatment of chronic diseases in my country.

Official Title
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Remote Blood Pressure Management Clinical Application Research

Conditions
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Hypertension

Intervention / Treatment
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* Device: Electronic remote blood pressure monitor
* Device: Ordinary household electronic sphygmomanometer
* Device: Office electronic sphygmomanometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of primary hypertension Must be aged at ≥18 years old and ≤75 years old Must have a smart phone and have the ability to use smart devices Must be local permanent resident population who volunteered to participate in the study and received a 2-year follow-up Must sign informed consent Exclusion Criteria: Participated in other clinical trials within 4 weeks before the start of this study The systolic blood pressure in the office was ≥180 mmHg, and/or the diastolic blood pressure was ≥110 mmHg Uremia, creatinine>250umol/l History of acute heart disease in the past three months Terminal diseases such as malignant tumors Severe cognitive impairment Severe diabetes patients (glycated hemoglobin>11%) Severe valvular heart disease, cardiomyopathy, and poor heart function Atrial fibrillation and atrioventricular block Arm circumference >35cm or <26cm Spouse or relatives have been included in this research Pregnant or breastfeeding women Live in an unfixed state

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote blood pressure management group<br>Remote blood pressure management group through remote blood pressure management the platform realizes functions such as automatic upload of patient measurement data, intelligent analysis, and early warning reminders | Device: Electronic remote blood pressure monitor<br>* Remote blood pressure management group through remote blood pressure management the platform realizes functions such as automatic upload of patient measurement data, intelligent analysis, and early warning reminders<br>|
| Other: Non-remote blood pressure management group<br>Non-remote blood pressure management group is distributed a set of ordinary household electronic sphygmomanometer, and the blood pressure is recorded by themselves at home following routine community office follow-up | Device: Ordinary household electronic sphygmomanometer<br>* One group is distributed a set of ordinary household electronic sphygmomanometer, and the blood pressure is recorded by themselves at home following routine community office follow-up<br>|
| Other: Routine blood pressure management group<br>Routine blood pressure management group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure | Device: Office electronic sphygmomanometer<br>* One group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure level(SBP and DBP) | Blood pressure level(SBP and DBP) | 2years | 
| Blood pressure compliance rate(SBP and DBP) | Blood pressure compliance rate(SBP and DBP) | 2years | 
| Cardiovascular risk assessment | Cardiovascular risk assessment | 2years | 
| Economic benefit | Compare economic benefit among the three groups by counting the cost of hypertension treatment and the cost of hospitalization due to complications of hypertension of patients in every group. | 2years | 
| improved level of quality of life | Compare improved level of quality of life among the three groups by counting the proportions of patients with improvement of lifestyle and living habits in every group.The content of improvement of lifestyle and living habits mainly including reduction of the frequency and amount of smoking, drinking, high-salt diet and high-fat diet, increase of the frequency and amount of exercise, and so on. | 2years | 
| Clinical prognosis assessment | Compare clinical prognosis among the three groups by counting incidence of non-fatal acute myocardial infarction, non-fatal stroke, hospitalization for unstable angina, hospitalization for worsening heart failure in every group. | 2years | 
| Therapeutic compliance | Compare therapeutic compliance among the three groups by counting the proportions of patients taking medication on time and regularly receiving follow-up at office in every group. | 2years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension;, Telemedicine;, Remote blood pressure monitoring