AI-Empowered Expert Prescription Intervention for Improving Cardiovascular Prognosis Among Primary-Care Hypertensive Populations: A Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14,400
- 主要终点
- Primary 1
研究概览
简要总结
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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.
排除标准
- 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.
研究组 & 干预措施
Intervention Group
AI-generated personalized health report + cardiologist face-to-face prescription optimization + integrated management
干预措施: AI-powered personalized health report with cardiologist consultation and prescription optimization (Behavioral)
Internal Control Group
Integrated management (follow-up, education, quality control) without AI report and cardiologist consultation
干预措施: Integrated management (follow-up, education, quality control) without AI report and cardiologist consultation (Behavioral)
External Control Group
Routine local hypertension management without any study-added intervention
结局指标
主要结局
Primary 1
时间窗: 18 months from baseline
Proportion of Participants Achieving Office Blood Pressure \< 130/80 mmHg at 18 Months
Primary 2
时间窗: 48 Months or longer from baseline
Composite Incidence of Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Heart Failure Hospitalization, and Cardiovascular Death at 48 Months or longer.
次要结局
- Secondary 1(Baseline to 18 months)
- Secondary 2(18 months from baseline)
- Secondary 3(18 Months from baseline)
- Secondary 4(18 Months from baseline)
- Secondary 5(48 Months or longer from baseline)
- Secondary 6(48 Months or longer from baseline)
- Secondary 7(48 Months or longer from baseline)
- Secondary 8(48 Months or longer from baseline)
研究者
标识符
- NCT 编号
- NCT07845448
- 其他研究编号
- 2026073
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (4年后)
- 研究完成日期
- (4年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
Whether individual participant data will be shared is currently undecided. The final decision will depend on ethical approval, informed consent provisions, and compliance with applicable Chinese data protection regulations. If shared, data will be de-identified and made available only through a controlled access mechanism.