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To explore whether the application of intelligent hypertension management system can effectively reduce blood pressure in hypertensive patients. A total of 320 eligible subjects will be recruited and randomization to two groups. The standard care group (n=160) will receive conventional hypertension treatment with baseline data collected.Wearable blood pressure monitoring device management group (intervention group, n=160) will receive blood pressure monitoring remotely everyday and antihypertension medication treatment. Primary outcome is Net change in systolic blood pressure from baseline to 3 months follow-up. Secondary outcomes include Net change in diastolic blood pressure hypertension control ratio (BP < 140/90 mmHg)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The standard care group | Active Comparator |
| |
| Intelligent intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intelligent Hypertension Management System | Device | The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net change in systolic blood pressure from baseline to 3 months follow-up | one and three months after study |
| Measure | Description | Time Frame |
|---|---|---|
| Net change in diastolic blood pressure | one and three months after study | |
| Hypertension control ratio (BP < 140/90 mmHg) | one and three months after study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai tongren hospital | Shanghai | Shanghai Municipality | 200050 | China | ||
| Shanghai Fifth Rehabilitation Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38086588 | Derived | Yu H, Chen X, Xia J, Hou L. Effect of intelligent hypertension management system on blood pressure: protocol for a randomised controlled multicentre trial. BMJ Open. 2023 Dec 12;13(12):e074580. doi: 10.1136/bmjopen-2023-074580. |
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The data that support the findings of this study are available in ClinicalTrials. gov at https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000CFXV\&selectaction=Edit\&uid=U0004XRB\&ts=32\&cx=-oc8exc. And can be accessed with reference number: NCT05526300. The individual deidentified participant data (including data dictionaries) will be available. All of the individual participant data collected during the trial will be shared after de-identification. The study protocol, and statistical analysis plan will be available. The data will become available Immediately following publication and with no end date. The data will be shared with researchers who wish to access the data to help patients for non-profit purposes. Data are available indefinitely at ClinicalTrials. gov.
The data will become available Immediately following publication and with no end date. T
The data will be shared with researchers who wish to access the data to help patients for non-profit purposes.
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| The standard care | Other | The standard care |
|
| Shanghai |
| China |
| Songjiang hospital, Shanghai jiaotong University, School of medicine | Shanghai | China |