"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Revascularization Patients (SMART II)

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 Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Diabete Mellitus; Hyperlipidemia; Post PCI; Post CABG
• Intervention / Treatment: Behavioral: Smart family doctor; Behavioral: Health manager; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 951
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lihua Zhang, PhD; Phone Number: 8601060866780; Email: zhanglihua@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Smart family doctor" assisted management; "Smart family doctor", an AI-assisted applications with personalized interactions in 24 hours and 7 days a week.	Behavioral: Smart family doctor; 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'.
Experimental: Health managers; 3-hour health management guidance from a health manager once a week.	Behavioral: Health manager; 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.
Placebo Comparator: Usual care; Usual post-surgery management	Behavioral: Usual Care; Participants will receive usual secondary prevention management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Rate	The proportion of patients who have smoked within the past month.	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
Fasting blood glucose	Fasting blood glucose analyzed at central lab.	6-month
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%.	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
HbA1c	HbA1c 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

Other Outcome Measures

Outcome Measure	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).	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
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
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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xin Yuan, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: smartphone; AI-assisted; metabolic management; Smart family doctor; Revascularization management
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus; Hyperlipidemias
• Other Study ID Numbers: FW-YX-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: At the end of the study
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No