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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-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Smart family doctor" assisted management | Experimental | "Smart family doctor", an AI-assisted applications with personalized interactions in 24 hours and 7 days a week. |
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| Health managers | Experimental | 3-hour health management guidance from a health manager once a week. |
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| Usual care | Placebo Comparator | Usual post-surgery management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart family doctor | Behavioral | 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Blood glucose Control Rate | The proportion of patients with HbA1c less than 7%. |
| 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 |
| BMI | Body mass index (BMI) is calculated as weights (kg) divided by the square of heights (meters). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihua Zhang, PhD | Contact | 8601060866780 | zhanglihua@fuwai.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Yuan, PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
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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 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.
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 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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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.
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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. |
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| Usual Care | Behavioral | Participants will receive usual secondary prevention management. |
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| 6-month |
| Blood lipid Control Rate | The proportion of patients with LDL-C less than 1.4mmol/L. | 6-month |
| Systolic blood pressure | Systolic blood pressure measured at the local site. | 6-month |
| Diastolic blood pressure | Diastolic blood pressure measured at the local site. | 6-month |
| Fasting blood glucose | Fasting blood glucose analyzed at central lab. | 6-month |
| HbA1c | HbA1c analyzed at central lab. | 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 |
| 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. | 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. | 6-month |
| Smoking Rate | The proportion of patients who have smoked within the past month. | 6-month |
| 6-month |
| Waist circumference | Waist circumference is measured at local site. | 6-month |
| Rehospitalization rate | The proportion of patients who had hospitalization | 6-month |
| The number of emergency visit | The number of emergency visit during follow-up period | 6-month |
| System usability (system usability scale) | System usability measured by system usability scale. The proportion of patients who scaled system usability more than 68 points. | 6-month |
| Subgroup-age | Primary outcome analyses in age subgroups: <=65, >65 years | 6-month |
| Subgroup-sex | Primary outcome analyses in sex subgroups: women, men | 6-month |
| Subgroup-education level | Primary outcome analyses in education level subgroups: less than high school, high school or higher | 6-month |
| Subgroup-smoking status | Primary outcome analyses in smoking status subgroups: current smoking, no smoking | 6-month |
| Subgroup-baseline BP level | Primary outcome analyses in baseline BP level subgroups: SBP/DBP>=130/80 mmHg, <130/80 mmHg | 6-month |
| Subgroup-baseline LDL-C level | Primary outcome analyses in baseline LDL-C level subgroups: <1.4 mmolL, >=1.4 mmol/L | 6-month |
| Subgroup-baseline HbA1c level | Primary outcome analyses in baseline HbA1c level subgroups: <7%, >=7% | 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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