Remote Blood Pressure Management Clinical Application Research

Qingdao University

Status: Unknown

Conditions: Hypertension

Treatments: Device: Electronic remote blood pressure monitor; Device: Office electronic sphygmomanometer; Device: Ordinary household electronic sphygmomanometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04690478

20-3-4-54-nsh

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,050 participants in 3 patient groups

Remote blood pressure management group

Experimental group

Description:

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

Treatment:

Device: Electronic remote blood pressure monitor

Non-remote blood pressure management group

Other group

Description:

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

Treatment:

Device: Ordinary household electronic sphygmomanometer

Routine blood pressure management group

Other group

Description:

Routine blood pressure management group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure

Treatment:

Device: Office electronic sphygmomanometer