HypertensionNCT04690478
Remote Blood Pressure Management Clinical Application Research
A study testing Electronic remote blood pressure monitor, Ordinary household electronic sphygmomanometer and Office electronic sphygmomanometer in people with Hypertension, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Electronic remote blood pressure monitor, Ordinary household electronic sphygmomanometer and Office electronic sphygmomanometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Remote electronic sphygmomanometer
Qingdao, Shandong, 266000
Yu haichu, master, +86 18661809671, haichuyu@163.com
Sun guixia, master, +86 18661805887, haichuyu@163.com
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Electronic remote blood pressure monitor, Ordinary household electronic sphygmomanometer, Office electronic sphygmomanometer
- Keywords
- Hypertension;, Telemedicine;, Remote blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic remote blood pressure monitorDevice
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
Ordinary household electronic sphygmomanometerDevice
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
Office electronic sphygmomanometerDevice
One group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Remote blood pressure management group | Experimental | 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 Receives: Device: Electronic remote blood pressure monitor |
| Non-remote blood pressure management group | Other | 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 Receives: Device: Ordinary household electronic sphygmomanometer |
| Routine blood pressure management group | Other | Routine blood pressure management group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure Receives: Device: Office electronic sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure level(SBP and DBP)
Blood pressure level(SBP and DBP)
Measured: 2years
Blood pressure compliance rate(SBP and DBP)
Blood pressure compliance rate(SBP and DBP)
Measured: 2years
Cardiovascular risk assessment
Cardiovascular risk assessment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jun 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu haichu, master, Study chair, Affiliated Cardiovascular Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690478
- Sponsor's protocol ID
- 20-3-4-54-nsh
- Status last verified
- Feb 2022
- First submitted
- 8 Dec 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40764960
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Blood Pressure Management Clinical Application Research
- ClinicalTrials.gov ID
- NCT04690478
- Acronym / sponsor ID
- 20-3-4-54-nsh
- Conditions
- Hypertension
- Keywords
- Hypertension;, Telemedicine;, Remote blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote blood pressure management group | Experimental | Device: Electronic remote blood pressure monitorRemote 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 | Other | Device: Ordinary household electronic sphygmomanometerNon-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 | Other | Device: Office electronic sphygmomanometerRoutine blood pressure management group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic remote blood pressure monitorRemote 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 | Remote blood pressure management group |
| Ordinary household electronic sphygmomanometerOne 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 | Non-remote blood pressure management group |
| Office electronic sphygmomanometerOne group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure | Device | Routine blood pressure management group |
Primary outcome
Blood pressure level(SBP and DBP)
Time frame: 2years
Blood pressure level(SBP and DBP)
Blood pressure compliance rate(SBP and DBP)
Time frame: 2years
Blood pressure compliance rate(SBP and DBP)
Cardiovascular risk assessment
Time frame: 2years
Cardiovascular risk assessment
Economic benefit
Time frame: 2years
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
Time frame: 2years
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
Time frame: 2years
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
Time frame: 2years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Derived from this study: PubMed 40764960Teng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu haichu, master study chair
Affiliated Cardiovascular Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic remote blood pressure monitor, Ordinary household electronic sphygmomanometer and Office electronic sphygmomanometer in people with Hypertension, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu haichu, master (+86 18661809671, haichuyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure level(SBP and DBP) (time frame: 2years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.