Remote Blood Pressure Management Clinical Application Research

NCT ID: NCT04690478

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Electronic remote blood pressure monitor

Intervention Type DEVICE

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

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

Group Type OTHER

Ordinary household electronic sphygmomanometer

Intervention Type DEVICE

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

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

Group Type OTHER

Office electronic sphygmomanometer

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Office electronic sphygmomanometer

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu haichu, master

Role: STUDY_CHAIR

Affiliated Cardiovascular Hospital of Qingdao University

Locations

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Remote electronic sphygmomanometer

Qingdao, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu haichu, master

Role: CONTACT

+86 18661809671

Sun guixia, master

Role: CONTACT

+86 18661805887

Facility Contacts

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Yu haichu, master

Role: primary

+86 18661809671

Sun guixia, master

Role: backup

+86 18661805887

References

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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.

Reference Type DERIVED
PMID: 40764960 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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20-3-4-54-nsh

Identifier Type: -

Identifier Source: org_study_id

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