Remote Blood Pressure Management Clinical Application Research

Hypertension Clinical Trial

Official title:

Remote Blood Pressure Management Clinical Application Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04690478
• Other study ID #: 20-3-4-54-nsh
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: Yu haichu, master
• Phone: +86 18661809671
• Email: haichuyu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Electronic remote blood pressure monitor
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
• Ordinary household electronic sphygmomanometer
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
• Office electronic sphygmomanometer
One group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure

Locations

Country	Name	City	State
China	Remote electronic sphygmomanometer	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure level(SBP and DBP)	Blood pressure level(SBP and DBP)	2years
Primary	Blood pressure compliance rate(SBP and DBP)	Blood pressure compliance rate(SBP and DBP)	2years
Primary	Cardiovascular risk assessment	Cardiovascular risk assessment	2years
Primary	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
Primary	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
Primary	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
Primary	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