Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Suppor
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 co
| Condition(s) | Hypertension |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 remainin |
| Who can participate | Inclusion Criteria: 1. 35 ≤ Age \< 80 years. 2. Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period. 3. Diagnosed with hypertension, with SBP ≥140mmHg at screening. 4. Currently taking 0 or 2 classes of antihypertensive medications (A/C/D), with or without concurrent use of class B. 5. Willing to participate in the trial and capable of providing written informed consent. Exclusion Criteria: 1. Physician-diagnosed or suspected secondary hypertension (e.g., hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug-induced, or rare monogenic genetic disease). 2. SBP ≥180mmHg |
| Ages | 35 Years to 79 Years |
| Sex | All |
| Lead sponsor | China National Center for Cardiovascular Diseases |
| Locations | Shenzhen, Shenzhen, China |
| Start date | 2025-05-26 |
| NCT ID | NCT06828692 |
| Official listing | https://clinicaltrials.gov/study/NCT06828692 |