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This trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of CDSS in primary care settings in China. Primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). A total of 51 primary care sites are randomized to three groups, with 17 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 17 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 17 sites to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (CG+ML) | Experimental |
| |
| Group B (CG+ICG+ML) | Experimental |
| |
| Group C (UC) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A (clinical guideline+machine learning) | Combination Product | Group A (CG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG) and machine learning (ML) approach. |
| Measure | Description | Time Frame |
|---|---|---|
| hierarchical composite outcome | The primary outcome of the trial is a hierarchical composite outcome, evaluated using the Win-ratio method in the following order:
| Baseline; 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months | Baseline; 3 months | |
| Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months | Baseline; 1 month; 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety outcome | Safety outcomes include serious adverse events, non-serious adverse events, such as symptomatic hypotension or SBP <90 mmHg, injury falls, syncope, and bradycardia (heart rate <50 beats/minute) during study periods. | Baseline; 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofang Yan | Contact | 0086 10 60686871 | yanxiaofang@fuwai.com | |
| Xin Zheng | Contact | 0086 10 60866719 | zhengxin@fuwai.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Zheng | Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences | Recruiting | Shenzhen | Shenzhen | China |
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| Group B (clinical guideline+impedance cardiograph+machine learning) | Combination Product | Group B (CG+ICG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG), hemodynamic parameters measured by impedance cardiograph (ICG), and machine learning (ML) approach. |
|
| Group C (usual care) | Other | Control group, the physicians manage the hypertensive patients according to their knowledge and experiences. |
|
| Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months | 3 months |
| Changes in hemodynamic parameters measured by ICG from baseline to 3 months | Including dynamic parameters (heart rate and cardiac index), resistance parameters (arterial stiffness index and systemic vascular resistance index), and volume parameters (thoracic blood volume saturation) | Baseline; 3 months |
| Differences in the three-tier hierarchical composite primary outcomes and each component of the three-tier hierarchical composite primary outcome among intervention groups at 3 months | Baseline; 3 months |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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