"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients or Post Percutaneous Coronary Intervention Patients (SMART)

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Hypertension; Post Coronary Artery Bypass Grafting; Hyperlipidemia; Diabetes Mellitus; Post PCI

Treatments: Behavioral: Smart family doctor; Behavioral: Health manager

Study type: Interventional

Funder types: Other

Identifiers

NCT06615609

FW-YX-001

Details and patient eligibility

About

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.

Enrollment: 536 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• History of CABG surgery or PCI with history of 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
• Use of a smartphone.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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536 participants in 2 patient groups, including a placebo group

"Smart family doctor" assisted management plus health managers

Experimental group

Description:

"Smart family doctor", an AI-assisted applications with personalized interactions and 3-hour health management guidance from a health manager once a week.

Treatment:

Behavioral: Health manager

Behavioral: Smart family doctor

Usual care: health managers

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Health manager