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RecruitingNot ApplicableNCT06828692

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

Sponsor

China National Center for Cardiovascular Diseases

Enrollment

2,160 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

Hypertension

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.

Eligibility

Min Age: 35 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a computer-based decision support system using artificial intelligence and blood pressure patterns can help doctors choose personalized blood pressure medications in primary care. You may be eligible if... - You are between 35 and 79 years old - You have been diagnosed with high blood pressure, with a reading of 140 mmHg or higher - You are currently taking 0 or 2 types of blood pressure medication - You attend the clinic regularly and are not planning to travel away during the study You may NOT be eligible if... - Your blood pressure is very severe (180/110 mmHg or higher) - You have a known cause of high blood pressure from another condition (like kidney disease or a hormone tumor) - You have a history of heart disease, heart failure, or chronic kidney disease - You are pregnant, breastfeeding, or planning to become pregnant - You have cognitive difficulties or poor past compliance with medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTGroup 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_PRODUCTGroup 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.

OTHERGroup C (usual care)

Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.

Locations(1)

Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences

Shenzhen, Shenzhen, China

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NCT06828692

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