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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore attivo: 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. |
|
Nessun intervento: External Control Group
Routine local hypertension management without any study-added intervention |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Primary 1
Lasso di tempo: 18 months from baseline
|
Proportion of Participants Achieving Office Blood Pressure < 130/80 mmHg at 18 Months |
18 months from baseline
|
|
Primary 2
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Secondary 1
Lasso di tempo: Baseline to 18 months
|
Change in Office Systolic and Diastolic Blood Pressure at 18 Months |
Baseline to 18 months
|
|
Secondary 2
Lasso di tempo: 18 months from baseline
|
Conventional Standard Hypertension Control (<140/90mmHg) Rate at 18 Months |
18 months from baseline
|
|
Secondary 3
Lasso di tempo: 18 Months from baseline
|
Medication Adherence Rate Measured by Morisky Scale at 18 Months |
18 Months from baseline
|
|
Secondary 4
Lasso di tempo: 18 Months from baseline
|
Hypertension Knowledge Awareness Rate at 18 Months |
18 Months from baseline
|
|
Secondary 5
Lasso di tempo: 48 Months or longer from baseline
|
Incidence of Individual Cardiovascular Events at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 6
Lasso di tempo: 48 Months or longer from baseline
|
Cardiovascular-Specific Mortality at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 7
Lasso di tempo: 48 Months or longer from baseline
|
All-Cause Mortality at 48 Months or longer |
48 Months or longer from baseline
|
|
Secondary 8
Lasso di tempo: 48 Months or longer from baseline
|
Long-Term Blood Pressure Control (<130/80mmHg) at 48 Months or longer |
48 Months or longer from baseline
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Malattie cardiache
- Malattie metaboliche
- Disturbi del metabolismo del glucosio
- Disturbi del metabolismo lipidico
- Malattie nutrizionali e metaboliche
- Ictus
- Arresto cardiaco
- Ipertensione
- Diabete mellito
- Ischemia miocardica
- Dislipidemie
- Malattia coronarica
- Fattori socioeconomici
- Caratteristiche della popolazione
- Tecnologia, industria e agricoltura
- Tecnologia
- Stato educativo
- Quality Control
Altri numeri di identificazione dello studio
- 2026073
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
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