"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Revascularization Patients

NCT07273513 | Not Yet Recruiting DMC

• 1 other identifier: FW-YX-002
• Study Type: interventional
• Target: 951
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Post PCI; Post CABG; Hypertension; Diabete Mellitus; Hyperlipidemia

Keywords

smartphone; AI-assisted; Revascularization management; metabolic management; Smart family doctor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Blood Pressure Control Rate

  6-month

• Blood glucose Control Rate

  6-month

• Blood lipid Control Rate

  6-month

• Systolic blood pressure

  6-month

• Diastolic blood pressure

  6-month

Other Outcomes (13)

• Major adverse cardiovascular events (MACE)

  6-month

• BMI

  6-month

• Waist circumference

  6-month

Study Arms (3)

"Smart family doctor" assisted management

EXPERIMENTAL

"Smart family doctor", an AI-assisted applications with personalized interactions in 24 hours and 7 days a week.

Behavioral: Smart family doctor

Health managers

EXPERIMENTAL

3-hour health management guidance from a health manager once a week.

Behavioral: Health manager

Usual care

PLACEBO COMPARATOR

Usual post-surgery management

Behavioral: Usual Care

Interventions

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'.

"Smart family doctor" assisted management

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.

Health managers

Usual Care BEHAVIORAL

Participants will receive usual secondary prevention management.

Usual care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Xin Yuan, PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihua Zhang, PhD

CONTACT

8601060866780; zhanglihua@fuwai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data manager and statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the end of the study
• 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.