Remote Blood Pressure Management Clinical Application Research
1 other identifier
interventional
1,050
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Jun 2020
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 8, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedFebruary 17, 2022
February 1, 2022
2.8 years
December 8, 2020
February 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Study Arms (3)
Remote blood pressure management group
EXPERIMENTALRemote 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
Non-remote blood pressure management group
OTHERNon-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
Routine blood pressure management group
OTHERRoutine blood pressure management group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure
Interventions
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
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
One group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Remote electronic sphygmomanometer
Qingdao, Shandong, 266000, China
Related Publications (1)
Teng TQ, Sun GX, Yu ZY, Liu ZS, Wang T, Wu Q, Qin RR, Wang MM, Chen R, Xu JC, Zhang N, Song BX, Liu X, Zhang YY, Yu HC. Efficiency of remote monitoring and guidance in blood pressure management: a randomized controlled trial : The role of remote monitoring in improving hypertension management. BMC Med. 2025 Aug 5;23(1):459. doi: 10.1186/s12916-025-04278-6.
PMID: 40764960DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yu haichu, master
Affiliated Cardiovascular Hospital of Qingdao University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2020
First Posted
December 30, 2020
Study Start
June 1, 2020
Primary Completion
March 31, 2023
Study Completion
June 30, 2023
Last Updated
February 17, 2022
Record last verified: 2022-02