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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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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-CABG (coronary artery bypass grafting) patients or post-PCI (percutaneous coronary intervention) patients. A randomized controlled trial design will be used, involving approximately 5-10 hospitals and 536 participants. Eligible participants are adults aged 18 or older, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Smart family doctor" assisted management plus health managers | Experimental | "Smart family doctor", an AI-assisted applications with personalized interactions and 3-hour health management guidance from a health manager once a week. |
|
| Usual care: health managers | Placebo Comparator | 3-hour health management guidance from a health manager once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart family doctor | Behavioral | Based on health managers, participants were additionally 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| The control rates of hypertension, diabetes and hyperlipidemia | All cretria are meet:
| 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Control Rate | The proportion of patients with systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg. | 6-month |
| Smoking Rate | The proportion of patients who have smoked within the past month. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events (MACE) | The composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization due to cardiovascular disease. | 6-month |
| C-reactive protein |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihua Zhang Zhang, PhD | Contact | 8601060866780 | zhanglihua@fuwai.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Yuan, PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinjiang's First Affiliated Hospital of medical university | Recruiting | Ürümqi | Xinjiang | 102300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41218945 | Derived | Lei L, Li J, Zhang L, Yuan X, Diao X, Qi L, Wang Y, Du W, Zhao W, Hu S. Design and rationale of the artificial intelligent dialogue System assisted comprehensive Management of secondary prevention Among post coronary aRtery bypass graft patienTs (SMART): protocol for a randomised controlled trial for postcoronary artery bypass grafting management. BMJ Open. 2025 Nov 11;15(11):e106447. doi: 10.1136/bmjopen-2025-106447. |
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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 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.
At the end of the study
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 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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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 or post-PCI patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-CABG 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.
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Data manager and statistician.
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|
| Health manager | Behavioral | 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. The research team will provide participants with one smart band, requiring them to wear the band daily to collect health data during the 6-month study period. |
|
| 6-month |
| Total cholesterol | Total cholesterol analyzed at central lab. | 6-month |
| LDL-C | LDL-C analyzed at central lab. | 6-month |
| HDL-C | HDL-C analyzed at central lab. | 6-month |
| Triglycerides | Triglycerides analyzed at central lab. | 6-month |
| Small dense LDL-C | Small dense LDL-C analyzed at central lab. | 6-month |
| Lipoprotein (a) | Lipoprotein (a) analyzed at central lab. | 6-month |
| Fasting blood glucose | Fasting blood glucose analyzed at central lab. | 6-month |
| HbA1c | HbA1c levels analyzed at central lab. | 6-month |
| Physical Activity Level | Assessed using the International Physical Activity Questionnaire (IPAQ) and decribed as total MET of walking, moderate, or high intensity physical activity. | 6-month |
| Quality of life using the Short Form Health Survey (SF-12v2) | Quality of life using the Short Form Health Survey (SF-12v2). The higher score indicated the better quality of life. | 6-month |
| Coronary artery disease-related quality of life | Coronary artery disease-related quality of life assessed with the Seattle Angina Questionnaire (SAQ). The higher score indicated the better coronary artery disease-related quality of life. | 6-month |
| Psychological status | Psychological status evaluated using the 9-item Patient Health Questionnaire (PHQ-9). The higher score indicated the worse psychological status | 6-month |
| Cognitive function | Cognitive function assessed with the Mini-Cog test. The higher score indicated the better conginition. | 6-month |
C-reactive protein (CRP) analyzed at central lab.
| 6-month |
| interleukin-6 | Interleukin-6 (IL-6) is analyzed at central lab. | 6-month |
| Interleukin-10 | Interleukin-10 (IL-10) is analyzed at central lab. | 6-month |
| Interleukin-1β (IL-1β) | Interleukin-1β (IL-1β) is analyzed at central lab. | 6-month |
| tumor necrosis factor-α (TNF-α) | Tumor necrosis factor-α (TNF-α) is analyzed at central lab. | 6-month |
| prostaglandin | prostaglandin (PG) is analyzed at central lab. | 6-month |
| Intercellular adhesion molecule-1 | Intercellular adhesion molecule-1 (ICAM-1) is analysed at central lab. | 6-month |
| Von Willebrand factor | Von Willebrand factor (vWF) is analyzed at central lab. | 6-month |
| Urinary albumin-to-creatinine ratio | Urinary albumin-to-creatinine ratio is calculated as urine albumin divided by urine creatinine. | 6-month |
| Urinary sodium excretion rate | Urinary sodium excretion rate is analyzed at central lab. | 6-month |
| BMI | Body mass index (BMI) is calculated as weights (kg) divided by the square of heights (meters). | 6-month |
| Waist circumference | Waist circumference is measured at local site. | 6-month |
| Cost-effectiveness analysis | The incremental cost-effectiveness ratio (ICER): the additional cost per patient achieving target control of hypertension, dyslipidemia, or diabetes. | 6-month |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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