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Remote Blood Pressure Management Clinical Application Research

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electronic remote blood pressure monitor
Ordinary household electronic sphygmomanometer
Office electronic sphygmomanometer
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension;, Telemedicine;, Remote blood pressure monitoring

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Remote electronic sphygmomanometerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Remote blood pressure management group

Non-remote blood pressure management group

Routine blood pressure management group

Arm Description

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

Outcomes

Primary Outcome Measures

Blood pressure level(SBP and DBP)
Blood pressure level(SBP and DBP)
Blood pressure compliance rate(SBP and DBP)
Blood pressure compliance rate(SBP and DBP)
Cardiovascular risk assessment
Cardiovascular risk assessment
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2020
Last Updated
February 16, 2022
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT04690478
Brief Title
Remote Blood Pressure Management Clinical Application Research
Official Title
Remote Blood Pressure Management Clinical Application Research
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension;, Telemedicine;, Remote blood pressure monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote blood pressure management group
Arm Type
Experimental
Arm Description
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
Arm Title
Non-remote blood pressure management group
Arm Type
Other
Arm Description
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
Arm Title
Routine blood pressure management group
Arm Type
Other
Arm Description
Routine blood pressure management group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure
Intervention Type
Device
Intervention Name(s)
Electronic remote blood pressure monitor
Intervention Description
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
Intervention Name(s)
Ordinary household electronic sphygmomanometer
Intervention Description
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
Intervention Name(s)
Office electronic sphygmomanometer
Intervention Description
One group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure
Primary Outcome Measure Information:
Title
Blood pressure level(SBP and DBP)
Description
Blood pressure level(SBP and DBP)
Time Frame
2years
Title
Blood pressure compliance rate(SBP and DBP)
Description
Blood pressure compliance rate(SBP and DBP)
Time Frame
2years
Title
Cardiovascular risk assessment
Description
Cardiovascular risk assessment
Time Frame
2years
Title
Economic benefit
Description
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.
Time Frame
2years
Title
improved level of quality of life
Description
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.
Time Frame
2years
Title
Clinical prognosis assessment
Description
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.
Time Frame
2years
Title
Therapeutic compliance
Description
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.
Time Frame
2years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu haichu, master
Phone
+86 18661809671
Email
haichuyu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sun guixia, master
Phone
+86 18661805887
Email
haichuyu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu haichu, master
Organizational Affiliation
Affiliated Cardiovascular Hospital of Qingdao University
Official's Role
Study Chair
Facility Information:
Facility Name
Remote electronic sphygmomanometer
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu haichu, master
Phone
+86 18661809671
Email
haichuyu@163.com
First Name & Middle Initial & Last Name & Degree
Sun guixia, master
Phone
+86 18661805887
Email
haichuyu@163.com

12. IPD Sharing Statement

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Remote Blood Pressure Management Clinical Application Research

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