Clinical trial NCT04690478: Remote Blood Pressure Management Clinical Application Research
Official title: Remote Blood Pressure Management Clinical Application Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension;
Telemedicine;
Remote blood pressure monitoring
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure level(SBP and DBP)
timeFrame: 2years
measure: Blood pressure compliance rate(SBP and DBP)
timeFrame: 2years
measure: Cardiovascular risk assessment
timeFrame: 2years
measure: Economic benefit
timeFrame: 2years
measure: improved level of quality of life
timeFrame: 2years
measure: Clinical prognosis assessment
timeFrame: 2years
measure: Therapeutic compliance
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Remote electronic sphygmomanometer
state: Shandong
Study officials:
affiliation: Affiliated Cardiovascular Hospital of Qingdao University
name: Yu haichu, master
role: STUDY_CHAIR
References: