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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic remote blood pressure monitor | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu haichu, master | Contact | +86 18661809671 | haichuyu@163.com | |
| Sun guixia, master | Contact | +86 18661805887 | haichuyu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu haichu, master | Affiliated Cardiovascular Hospital of Qingdao University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Remote electronic sphygmomanometer | Recruiting | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40764960 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2020 | Dec 25, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2020 | Dec 25, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Ordinary household electronic sphygmomanometer | 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 |
|
| Office electronic sphygmomanometer | Device | One group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure |
|
| 2years |