A Cluster-Randomized Controlled Trial
AI-Empowered Expert Prescription Intervention for Improving Cardiovascular Prognosis Among Primary-Care Hypertensive Populations: A Cluster-Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
AI-generated personalized health report + cardiologist face-to-face prescription optimization + integrated management |
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. |
|
Active Comparator: Internal Control Group
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. |
|
No Intervention: External Control Group
Routine local hypertension management without any study-added intervention |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary 1
Time Frame: 18 months from baseline
|
Proportion of Participants Achieving Office Blood Pressure < 130/80 mmHg at 18 Months |
18 months from baseline
|
|
Primary 2
Time Frame: 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. |
48 Months or longer from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary 1
Time Frame: Baseline to 18 months
|
Change in Office Systolic and Diastolic Blood Pressure at 18 Months |
Baseline to 18 months
|
|
Secondary 2
Time Frame: 18 months from baseline
|
Conventional Standard Hypertension Control (<140/90mmHg) Rate at 18 Months |
18 months from baseline
|
|
Secondary 3
Time Frame: 18 Months from baseline
|
Medication Adherence Rate Measured by Morisky Scale at 18 Months |
18 Months from baseline
|
|
Secondary 4
Time Frame: 18 Months from baseline
|
Hypertension Knowledge Awareness Rate at 18 Months |
18 Months from baseline
|
|
Secondary 5
Time Frame: 48 Months or longer from baseline
|
Incidence of Individual Cardiovascular Events at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 6
Time Frame: 48 Months or longer from baseline
|
Cardiovascular-Specific Mortality at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 7
Time Frame: 48 Months or longer from baseline
|
All-Cause Mortality at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 8
Time Frame: 48 Months or longer from baseline
|
Long-Term Blood Pressure Control (<130/80mmHg) at 48 Months or longer |
48 Months or longer from baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Heart Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Lipid Metabolism Disorders
- Nutritional and Metabolic Diseases
- Stroke
- Heart Failure
- Hypertension
- Diabetes Mellitus
- Myocardial Ischemia
- Dyslipidemias
- Coronary Disease
- Socioeconomic Factors
- Population Characteristics
- Technology, Industry, and Agriculture
- Technology
- Educational Status
- Quality Control
Other Study ID Numbers
- 2026073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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