About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
History of CABG surgery or PCI with history of hypertension, diabetes, and dyslipidemia.
Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg
HbA1c no less than 7%
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Smart family doctor
BehavioralBased 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'.
Health manager
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Blood Pressure Control Rate
The proportion of patients with systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg.
Smoking Rate
The proportion of patients who have smoked within the past month.
Total cholesterol
Total cholesterol analyzed at central lab.
LDL-C
LDL-C analyzed at central lab.
Other outcomes
Major adverse cardiovascular events (MACE)
The composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization due to cardiovascular disease.
C-reactive protein
C-reactive protein (CRP) analyzed at central lab.
interleukin-6
Interleukin-6 (IL-6) is analyzed at central lab.
Interleukin-10
Interleukin-10 (IL-10) is analyzed at central lab.
Sponsors and contacts
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China National Center for Cardiovascular Diseases
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator