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

National Center for Cardiovascular Diseases

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07273513

FW-YX-002

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-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.

Enrollment: 951 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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951 participants in 3 patient groups, including a placebo group

"Smart family doctor" assisted management

Experimental group

Description:

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

Treatment:

Behavioral: Smart family doctor

Health managers

Experimental group

Description:

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

Treatment:

Behavioral: Health manager

Usual care

Placebo Comparator group

Description:

Usual post-surgery management

Treatment:

Behavioral: Usual Care