HypertensionNCT07845448
A Cluster-Randomized Controlled Trial
A study testing AI-powered personalized health report with cardiologist consultation and prescription optimization in people with Hypertension and Stroke, run by Second Affiliated Hospital of Nanchang University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Hypertension, Stroke, Cardiovascular
- What is being tested?
- AI-powered personalized health report with cardiologist consultation and prescription optimization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,400 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 9 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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:
Read more
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.
- Conditions
- Hypertension, Stroke, Cardiovascular, Coronary Heart Disease, Ischemic Heart Disease, Dyslipidaemia
- Being tested
- AI-powered personalized health report with cardiologist consultation and prescription optimization, Integrated management (follow-up, education, quality control) without AI report and cardiologist consultation
- Keywords
- AI-Powered Health Report, Artificial Intelligence, Digital Chronic Disease Management, Primary Care, Community-Based Hypertension Management, Hypertension, Blood Pressure Control, Rural Cardiovascular Health
- Medical subject headings
- Hypertension, Stroke, Coronary Disease, Myocardial Ischemia, Dyslipidemias, Diabetes Mellitus, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-powered personalized health report with cardiologist consultation and prescription optimizationBehavioural
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.
Integrated management (follow-up, education, quality control) without AI report and cardiologist consultationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | AI-generated personalized health report + cardiologist face-to-face prescription optimization + integrated management Receives: Behavioral: AI-powered personalized health report with cardiologist consultation and prescription optimization |
| Internal Control Group | Active comparator | Integrated management (follow-up, education, quality control) without AI report and cardiologist consultation Receives: Behavioral: Integrated management (follow-up, education, quality control) without AI report and cardiologist consultation |
| External Control Group | No intervention | Routine local hypertension management without any study-added intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary 1
Proportion of Participants Achieving Office Blood Pressure < 130/80 mmHg at 18 Months
Measured: 18 months from baseline
Primary 2
Composite Incidence of Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Heart Failure Hospitalization, and Cardiovascular Death at 48 Months or longer.
Measured: 48 Months or longer from baseline
Secondary outcomes (8)
Secondary 1
Change in Office Systolic and Diastolic Blood Pressure at 18 Months
Measured: Baseline to 18 months
Secondary 2
Conventional Standard Hypertension Control (<140/90mmHg) Rate at 18 Months
Measured: 18 months from baseline
Secondary 3
Medication Adherence Rate Measured by Morisky Scale at 18 Months
Measured: 18 Months from baseline
Secondary 4
Hypertension Knowledge Awareness Rate at 18 Months
Measured: 18 Months from baseline
Secondary 5
Incidence of Individual Cardiovascular Events at 48 Months or longer
Measured: 48 Months or longer from baseline
Secondary 6
Cardiovascular-Specific Mortality at 48 Months or longer
Measured: 48 Months or longer from baseline
Secondary 7
All-Cause Mortality at 48 Months or longer
Measured: 48 Months or longer from baseline
Secondary 8
Long-Term Blood Pressure Control (<130/80mmHg) at 48 Months or longer
Measured: 48 Months or longer from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion9 Sep 2031 (estimated)
- Study completion9 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845448
- Sponsor's protocol ID
- 2026073
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Empowered Expert Prescription Intervention for Improving Cardiovascular Prognosis Among Primary-Care Hypertensive Populations: A Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07845448
- Acronym / sponsor ID
- 2026073
- Conditions
- Hypertension, Stroke, Cardiovascular, Coronary Heart Disease, Ischemic Heart Disease, Dyslipidaemia
- Keywords
- AI-Powered Health Report, Artificial Intelligence, Digital Chronic Disease Management, Primary Care, Community-Based Hypertension Management, Hypertension, Blood Pressure Control, Rural Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14,400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 9 Sep 2031 (estimated)
- Study completion
- 9 Sep 2031 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: AI-powered personalized health report with cardiologist consultation and prescription optimizationAI-generated personalized health report + cardiologist face-to-face prescription optimization + integrated management |
| Internal Control Group | Active comparator | Behavioral: Integrated management (follow-up, education, quality control) without AI report and cardiologist consultationIntegrated management (follow-up, education, quality control) without AI report and cardiologist consultation |
| External Control Group | No intervention | –Routine local hypertension management without any study-added intervention |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-powered personalized health report with cardiologist consultation and prescription optimizationParticipants 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. | Behavioural | Intervention Group |
| Integrated management (follow-up, education, quality control) without AI report and cardiologist consultationParticipants 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. | Behavioural | Internal Control Group |
Primary outcome
Primary 1
Time frame: 18 months from baseline
Proportion of Participants Achieving Office Blood Pressure < 130/80 mmHg at 18 Months
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.
8 secondary outcomes
Secondary 1
Time frame: Baseline to 18 months
Secondary 2
Time frame: 18 months from baseline
Secondary 3
Time frame: 18 Months from baseline
Secondary 4
Time frame: 18 Months from baseline
Secondary 5
Time frame: 48 Months or longer from baseline
Secondary 6
Time frame: 48 Months or longer from baseline
Secondary 7
Time frame: 48 Months or longer from baseline
Secondary 8
Time frame: 48 Months or longer from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AI-powered personalized health report with cardiologist consultation and prescription optimization in people with Hypertension and Stroke, run by Second Affiliated Hospital of Nanchang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary 1 (time frame: 18 months from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.