Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07845448 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Cluster-Randomized Controlled Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
8,786 trials monitored
See 412 trials at risk
5,087 trials monitored
See 222 trials at risk
3,531 trials monitored
See 153 trials at risk
and 3 more diseases
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.
Trial Details
NCT Number NCT07845448
Lead Sponsor Second Affiliated Hospital of Nanchang University
Conditions
(from sponsor)
Hypertension, Stroke, Cardiovascular, Coronary Heart Disease, Ischemic Heart Disease, Dyslipidaemia, Diabete Mellitus, Heart Failure +3 more
Related terms Coronary Disease, Diabetes Mellitus, Dyslipidemias, Heart Failure, Hypertension, Myocardial Ischemia, Stroke
Enrollment 14,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov