Remote Blood Pressure Management Clinical Application Research

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Device: Electronic remote blood pressure monitor; Device: Ordinary household electronic sphygmomanometer; Device: Office electronic sphygmomanometer

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1050
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu haichu, master; Phone Number: +86 18661809671; Email: haichuyu@163.com
• Study Contact Backup: Name: Sun guixia, master; Phone Number: +86 18661805887; Email: haichuyu@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • Remote electronic sphygmomanometer
      • Contact: Yu haichu, master; Phone Number: +86 18661809671; Email: haichuyu@163.com
      • Contact: Sun guixia, master; Phone Number: +86 18661805887; Email: haichuyu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote blood pressure management group; 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; 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
Other: Non-remote blood pressure management group; 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; 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
Other: Routine blood pressure management group; Routine blood pressure management group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure	Device: Office electronic sphygmomanometer; One group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Study Chair: Yu haichu, master, Affiliated Cardiovascular Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Hypertension;; Telemedicine;; Remote blood pressure monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 20-3-4-54-nsh

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No