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Not Yet Recruiting NCT07845448

A Cluster-Randomized Controlled Trial

Conditions: Hypertension, Stroke, Cardiovascular, Coronary Heart Disease, Ischemic Heart Disease, Dyslipidaemia, Diabete Mellitus, Heart Failure, Cardiovascular Mortality, All Cause Mortality, Major Adverse Cardiac Event (MACE)

Sex: All
Ages: 35 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 14400
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.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 35 years, regardless of gender. * Meet the hypertension diagnostic criteria: untreated office SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg; or treated with office BP ≥ 130/80 mmHg; or with history of coronary heart disease, stroke, heart failure, diabetes, or chronic kidney disease and office BP ≥ 130/80 mmHg regardless of treatment status. * Have resided continuously in the township for at least 6 months with no plan for long-term relocation within 3 years. * Enrolled in the basic medical insurance system. * Willing to participate and provide written informed consent. Exclusion Criteria: * Pregnant or planning pregnancy within the study period. * Diagnosed with malignant tumors or terminal illnesses. * Severe mental disorders or cognitive impairment that precludes compliance with intervention and follow-up. * Concurrent participation in another hypertension intervention trial. * Refusal to cooperate with data collection, follow-up, or intervention procedures.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07845448). StuddyBuddy aggregates publicly available trial information.