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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
|
Comparador activo: 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. |
|
Sin intervención: External Control Group
Routine local hypertension management without any study-added intervention |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Primary 1
Periodo de tiempo: 18 months from baseline
|
Proportion of Participants Achieving Office Blood Pressure < 130/80 mmHg at 18 Months |
18 months from baseline
|
|
Primary 2
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secondary 1
Periodo de tiempo: Baseline to 18 months
|
Change in Office Systolic and Diastolic Blood Pressure at 18 Months |
Baseline to 18 months
|
|
Secondary 2
Periodo de tiempo: 18 months from baseline
|
Conventional Standard Hypertension Control (<140/90mmHg) Rate at 18 Months |
18 months from baseline
|
|
Secondary 3
Periodo de tiempo: 18 Months from baseline
|
Medication Adherence Rate Measured by Morisky Scale at 18 Months |
18 Months from baseline
|
|
Secondary 4
Periodo de tiempo: 18 Months from baseline
|
Hypertension Knowledge Awareness Rate at 18 Months |
18 Months from baseline
|
|
Secondary 5
Periodo de tiempo: 48 Months or longer from baseline
|
Incidence of Individual Cardiovascular Events at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 6
Periodo de tiempo: 48 Months or longer from baseline
|
Cardiovascular-Specific Mortality at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 7
Periodo de tiempo: 48 Months or longer from baseline
|
All-Cause Mortality at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 8
Periodo de tiempo: 48 Months or longer from baseline
|
Long-Term Blood Pressure Control (<130/80mmHg) at 48 Months or longer |
48 Months or longer from baseline
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades cardíacas
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Trastornos del metabolismo de los lípidos
- Enfermedades Nutricionales y Metabólicas
- Carrera
- Insuficiencia cardiaca
- Hipertensión
- Diabetes mellitus
- Isquemia miocardica
- Dislipidemias
- Enfermedad coronaria
- Factores socioeconómicos
- Características de la población
- Tecnología, industria y agricultura
- Tecnología
- Estado educativo
- Quality Control
Otros números de identificación del estudio
- 2026073
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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