NCT06828692

Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Support Systems for Personalized Guideline Accordant Antihypertensive Regimens in Primary Care: a Pragmatic Cluster Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,160 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 35 Years – 79 Years
• Healthy volunteers: Not accepted

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 remaining 17 sites to the control group.

Conditions

• Hypertension

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Group A (clinical guideline+machine learning)	Group A (CG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG) and machine learning (ML) approach.
COMBINATION_PRODUCT	Group B (clinical guideline+impedance cardiograph+machine learning)	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.
OTHER	Group C (usual care)	Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.

Timeline

• Start date: 2025-05-26
• Primary completion: 2026-02-28
• Completion: 2026-05-31
• First posted: 2025-02-14
• Last updated: 2026-02-12

Locations

1 site across 1 country: China