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

NCT ID: NCT07273513

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

951 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2027-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Post PCI Post CABG Hypertension Diabete Mellitus Hyperlipidemia

Keywords

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smartphone AI-assisted Revascularization management metabolic management Smart family doctor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Data manager and statistician.

Study Groups

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"Smart family doctor" assisted management

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

Group Type EXPERIMENTAL

Smart family doctor

Intervention Type 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'.

Health managers

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

Group Type EXPERIMENTAL

Health manager

Intervention Type 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.

Usual care

Usual post-surgery management

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Participants will receive usual secondary prevention management.

Interventions

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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'.

Intervention Type 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.

Intervention Type BEHAVIORAL

Usual Care

Participants will receive usual secondary prevention management.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Xin Yuan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xin Yuan, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Central Contacts

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Lihua Zhang, PhD

Role: CONTACT

Phone: 8601060866780

Email: [email protected]

Other Identifiers

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FW-YX-002

Identifier Type: -

Identifier Source: org_study_id