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A Cluster-Randomized Controlled Trial
Sponsor: Second Affiliated Hospital of Nanchang University
Summary
The goal of this study is to learn if an AI-generated personalized health report combined with face-to-face guidance from cardiologists can help rural adults with high blood pressure control their blood pressure better and reduce heart attacks and strokes. It will also assess the safety and practicality of this approach. The main questions it aims to answer are: Does this intervention increase the proportion of patients who achieve blood pressure below 130/80 mmHg at 18 months? Does it lower the rate of major cardiovascular events (heart attack, stroke, heart failure hospitalisation, or cardiovascular death) over 48 months or longer? Does it improve medication adherence, blood pressure levels, and health knowledge, and is it cost-effective? Researchers will compare three groups of townships: one receiving the full AI-plus-cardiologist intervention, one receiving the same follow-up and education but without the AI report and cardiologist consultation, and one continuing with usual local care. Participants will: Attend regular clinic visits for blood pressure measurements, lab tests, and questionnaires. If in the intervention group, receive an AI-generated personalised health report and a face-to-face consultation with a cardiologist, plus home blood pressure monitoring guidance and health education. Be followed for 48 months or longer to track their blood pressure and any cardiovascular events. All medications used are standard, widely approved blood pressure drugs; side effects are mild and manageable, and participants will be closely monitored. Participation is voluntary, and all personal data will be kept confidential. The study has ethics approval, and informed consent will be obtained from all participants.
Official title: AI-Empowered Expert Prescription Intervention for Improving Cardiovascular Prognosis Among Primary-Care Hypertensive Populations: A Cluster-Randomized Controlled Trial
Key Details
Gender
All
Age Range
35 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14400
Start Date
2026-09-10
Completion Date
2031-09-09
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
AI-powered personalized health report with cardiologist consultation and prescription optimization
Participants receive an AI-powered "2+N" health report covering individualized nutrition plans, lifestyle modification (exercise, weight, smoking, alcohol), and integrated management of hypertension, diabetes, dyslipidemia, hyperuricemia, hyperhomocysteinemia, and obesity. The AI draft is reviewed by a clinical nutritionist and cardiologists from a tertiary hospital. Face-to-face cardiologist consultations are provided for prescription optimization, medication titration, and treatment individualization. Grassroots providers receive training workshops, real-time consultation, monthly case discussions, and quarterly specialist visits. Participants also receive home BP monitoring guidance, regular follow-ups, and health education. All antihypertensives are standard marketed agents (CCB, ACEI, ARB, thiazides) used per guidelines; no investigational products.
Integrated management (follow-up, education, quality control) without AI report and cardiologist consultation
Participants receive the same integrated management package as the intervention group, including standardized capacity-building training for healthcare providers (excluding AI report interpretation modules), regular follow-up visits, conventional health education using generic hypertension prevention manuals (non-individualized), home blood pressure monitoring guidance, and the tiered quality control and incentive system. However, they do NOT receive the AI-generated "2+N" personalized health report or accompanying videos, do NOT have cardiologist-led face-to-face prescription training or on-site consultation, and do NOT receive specialist outreach visits. Antihypertensive medications are standard marketed agents prescribed per guidelines; no investigational products are involved. This arm serves as an active comparator to isolate the independent net effect of the AI plus cardiologist intervention component from the background integrated management package.