HypertensionSMART IINCT07273513
"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Revascularization Patients
A study testing Smart family doctor and Health manager in people with Hypertension and Diabete Mellitus, run by China National Center for Cardiovascular Diseases.
Trial summary
This study aims to evaluate the effect of an AI-assisted "Smart family doctor" digital health management tool on improving the control rates of hypertension, diabetes, and dyslipidemia in post-revascularization patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Diabete Mellitus, Hyperlipidemia
- What is being tested?
- Smart family doctor and Health manager
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 951 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 15 Jan 2027
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Underwent CABG or PCI more than 3 months prior and have concurrent hypertension, diabetes, and dyslipidemia.
- At least one of the following criteria is meet:
- Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg
- HbA1c no less than 7%
- LDL-C no less than 1.4 mmol/L
- Signed informed consent.
Who cannot join
- History of heart failure or severe arrhythmias.
- Presence of other severe underlying conditions such as cancer or liver and kidney insufficiency.
- Pregnancy, lactation, or plans for pregnancy within the next year.
- Cognitive, communication impairments, or limitations in daily activities.
- Unable to use smartphone.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate the effect of an AI-assisted "Smart family doctor" digital health management tool on improving the control rates of hypertension, diabetes, and dyslipidemia in post-revascularization patients. A randomized controlled trial design will be used, involving approximately 10-20 hospitals and 951 participants. Eligible participants are adults aged between 18 and 80 years, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.
- Conditions
- Hypertension, Diabete Mellitus, Hyperlipidemia, Post PCI, Post CABG
- Being tested
- Smart family doctor, Health manager, Usual Care
- Keywords
- smartphone, AI-assisted, Revascularization management, metabolic management, Smart family doctor
- Medical subject headings
- Hypertension, Diabetes Mellitus, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart family doctorBehavioural
Participants will be provided "Smart family doctor", which is an AI-assisted applications with personalized interactions. The content includes, but is not limited to: (1) General educational content, covering basic health knowledge on diseases, risk factors, and treatment methods; (2) Targeted health information, such as more specific guidance on blood pressure and blood sugar control, medication adherence, exercise, and smoking cessation; (3) Personalized disease management guidance, providing tailored reminders for patients regarding medication, diet, exercise, and medical visits. Patients can also directly report their latest self-measured blood pressure, blood lipid, blood sugar levels, and medication adherence to receive treatment and medication guidance from the 'Smart family doctor'.
Health managerBehavioural
Participants will received 3-hour health management guidance from a health manager once a week, including guidance on healthy lifestyle, medication treatment, and rehabilitation advice.
Usual CareBehavioural
Participants will receive usual secondary prevention management.
| Study group | Role | What they receive |
|---|---|---|
| "Smart family doctor" assisted management | Experimental | "Smart family doctor", an AI-assisted applications with personalized interactions in 24 hours and 7 days a week. Receives: Behavioral: Smart family doctor |
| Health managers | Experimental | 3-hour health management guidance from a health manager once a week. Receives: Behavioral: Health manager |
| Usual care | Placebo comparator | Usual post-surgery management Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The control rates of hypertension, diabetes and hyperlipidemia
All cretria are meet: 1) Systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg. 2) HbA1c less than 7%. 3) LDL-C less than 1.4 mmol/L.
Measured: 6-month
Secondary outcomes (14)
Blood Pressure Control Rate
The proportion of patients with systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg.
Measured: 6-month
Blood glucose Control Rate
The proportion of patients with HbA1c less than 7%.
Measured: 6-month
Blood lipid Control Rate
The proportion of patients with LDL-C less than 1.4mmol/L.
Measured: 6-month
Systolic blood pressure
Systolic blood pressure measured at the local site.
Measured: 6-month
Diastolic blood pressure
Diastolic blood pressure measured at the local site.
Measured: 6-month
Fasting blood glucose
Fasting blood glucose analyzed at central lab.
Measured: 6-month
HbA1c
HbA1c analyzed at central lab.
Measured: 6-month
Total cholesterol
Total cholesterol analyzed at central lab.
Measured: 6-month
LDL-C
LDL-C analyzed at central lab.
Measured: 6-month
HDL-C
HDL-C analyzed at central lab.
Measured: 6-month
Triglycerides
Triglycerides analyzed at central lab.
Measured: 6-month
Medication adherence (4-item Morisky Medication-Taking Adherence Scale)
Medication adherence measured by MMAS-4. The score range from 0 to 4. The higher score indicated the better medication adherence.
Measured: 6-month
Coronary artery disease-related quality of life (the Seattle Angina Questionnaire)
Coronary artery disease-related quality of life assessed with the Seattle Angina Questionnaire (SAQ). The score range from 0 to 100. The higher score indicated the better coronary artery disease-related quality of life.
Measured: 6-month
Smoking Rate
The proportion of patients who have smoked within the past month.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jan 2027 (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.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- Model description
- The intervention in this study is the implementation of the 'Smart family doctor' system, a digital health management tool designed to support secondary prevention in post-CABG patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-revascularization issues. It is powered by a large-scale, medical knowledge-enhanced conversational model, enabling personalized interactions with patients to guide their recovery and lifestyle management following surgery.
- Masking
- None (open label)
- Enrolment
- 951 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xin Yuan, China National Center for Cardiovascular Diseases
- Investigators
- Xin Yuan, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273513
- Sponsor's protocol ID
- FW-YX-002
- Acronym
- SMART II
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data that support the findings of this study are available from the corresponding author, upon reasonable request, only for authorized research. Their use is subjected to an agreement with the promotor (Fuwai Hospital) and the principal investigator (Dr Xin Yuan) of the SMART II study. Pseudonymised data that support the findings of this study are available from the promotor (Fuwai Hospital) upon reasonable request, subject to a specific agreement with the promotor (involving the principal investigator) and subject to regulatory proceedings due to data protection applicable laws. Access conditions are to be determined depending on the nature of the request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Revascularization Patients
- ClinicalTrials.gov ID
- NCT07273513
- Acronym / sponsor ID
- SMART II / FW-YX-002
- Conditions
- Hypertension, Diabete Mellitus, Hyperlipidemia, Post PCI, Post CABG
- Keywords
- smartphone, AI-assisted, Revascularization management, metabolic management, Smart family doctor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 951 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 9 Dec 2025 (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.
This study aims to evaluate the effect of an AI-assisted "Smart family doctor" digital health management tool on improving the control rates of hypertension, diabetes, and dyslipidemia in post-revascularization patients. A randomized controlled trial design will be used, involving approximately 10-20 hospitals and 951 participants. Eligible participants are adults aged between 18 and 80 years, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The intervention in this study is the implementation of the 'Smart family doctor' system, a digital health management tool designed to support secondary prevention in post-CABG patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-revascularization issues. It is powered by a large-scale, medical knowledge-enhanced conversational model, enabling personalized interactions with patients to guide their recovery and lifestyle management following surgery.
| Arm | Type | Receives |
|---|---|---|
| "Smart family doctor" assisted management | Experimental | Behavioral: Smart family doctor"Smart family doctor", an AI-assisted applications with personalized interactions in 24 hours and 7 days a week. |
| Health managers | Experimental | Behavioral: Health manager3-hour health management guidance from a health manager once a week. |
| Usual care | Placebo comparator | Behavioral: Usual CareUsual post-surgery management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years.
- Underwent CABG or PCI more than 3 months prior and have concurrent hypertension, diabetes, and dyslipidemia.
- At least one of the following criteria is meet:
- Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg
- HbA1c no less than 7%
Key exclusion criteria (5 listed)
- History of heart failure or severe arrhythmias.
- Presence of other severe underlying conditions such as cancer or liver and kidney insufficiency.
- Pregnancy, lactation, or plans for pregnancy within the next year.
- Cognitive, communication impairments, or limitations in daily activities.
- Unable to use smartphone.
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 |
|---|---|---|
| Smart family doctorParticipants will be provided "Smart family doctor", which is an AI-assisted applications with personalized interactions. The content includes, but is not limited to: (1) General educational content, covering basic health knowledge on diseases, risk factors, and treatment methods; (2) Targeted health information, such as more specific guidance on blood pressure and blood sugar control, medication adherence, exercise, and smoking cessation; (3) Personalized disease management guidance, providing tailored reminders for patients regarding medication, diet, exercise, and medical visits. Patients can also directly report their latest self-measured blood pressure, blood lipid, blood sugar levels, and medication adherence to receive treatment and medication guidance from the 'Smart family doctor'. | Behavioural | "Smart family doctor" assisted management |
| Health managerParticipants will received 3-hour health management guidance from a health manager once a week, including guidance on healthy lifestyle, medication treatment, and rehabilitation advice. | Behavioural | Health managers |
| Usual CareParticipants will receive usual secondary prevention management. | Behavioural | Usual care |
Primary outcome
The control rates of hypertension, diabetes and hyperlipidemia
Time frame: 6-month
All cretria are meet: 1) Systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg. 2) HbA1c less than 7%. 3) LDL-C less than 1.4 mmol/L.
14 secondary outcomes
Blood Pressure Control Rate
Time frame: 6-month
Blood glucose Control Rate
Time frame: 6-month
Blood lipid Control Rate
Time frame: 6-month
Systolic blood pressure
Time frame: 6-month
Diastolic blood pressure
Time frame: 6-month
Fasting blood glucose
Time frame: 6-month
HbA1c
Time frame: 6-month
Total cholesterol
Time frame: 6-month
LDL-C
Time frame: 6-month
HDL-C
Time frame: 6-month
Triglycerides
Time frame: 6-month
Medication adherence (4-item Morisky Medication-Taking Adherence Scale)
Time frame: 6-month
Coronary artery disease-related quality of life (the Seattle Angina Questionnaire)
Time frame: 6-month
Smoking Rate
Time frame: 6-month
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 18 Dec 2025.
- Individual participant dataSharing planned: Yes. Anonymized data that support the findings of this study are available from the corresponding author, upon reasonable request, only for authorized research. Their use is subjected to an agreement with the promotor (Fuwai Hospital) and the principal investigator (Dr Xin Yuan) of the SMART II study. Pseudonymised data that support the findings of this study are available from the promotor (Fuwai Hospital) upon reasonable request, subject to a specific agreement with the promotor (involving the principal investigator) and subject to regulatory proceedings due to data protection applicable laws. Access conditions are to be determined depending on the nature of the request.
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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.
Xin Yuan, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Smart family doctor and Health manager in people with Hypertension and Diabete Mellitus, run by China National Center for Cardiovascular Diseases.
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 7 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 18 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Contact Lihua Zhang, PhD (8601060866780, zhanglihua@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The control rates of hypertension, diabetes and hyperlipidemia (time frame: 6-month). 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 18 Dec 2025.