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

NCT ID: NCT06615609

Last Updated: 2025-12-08

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

RECRUITING

Clinical Phase

NA

Total Enrollment

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-24

Study Completion Date

2026-11-15

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-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.

Detailed Description

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Conditions

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Post Coronary Artery Bypass Grafting Hypertension Diabetes Mellitus Hyperlipidemia Post PCI

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 or post-PCI patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-CABG 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 plus health managers

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

Group Type EXPERIMENTAL

Smart family doctor

Intervention Type BEHAVIORAL

Based on health managers, participants were additionally 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 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. The research team will provide participants with one smart band, requiring them to wear the band daily to collect health data during the 6-month study period.

Usual care: health managers

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

Group Type PLACEBO_COMPARATOR

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. The research team will provide participants with one smart band, requiring them to wear the band daily to collect health data during the 6-month study period.

Interventions

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Smart family doctor

Based on health managers, participants were additionally 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. The research team will provide participants with one smart band, requiring them to wear the band daily to collect health data during the 6-month study period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

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

Locations

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Xinjiang's First Affiliated Hospital of medical university

Ürümqi, Xinjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lihua Zhang Zhang, PhD

Role: CONTACT

8601060866780

Facility Contacts

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Zhiying Wen

Role: primary

+8618129344576

References

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Lei L, Li J, Zhang L, Yuan X, Diao X, Qi L, Wang Y, Du W, Zhao W, Hu S. Design and rationale of the artificial intelligent dialogue System assisted comprehensive Management of secondary prevention Among post coronary aRtery bypass graft patienTs (SMART): protocol for a randomised controlled trial for postcoronary artery bypass grafting management. BMJ Open. 2025 Nov 11;15(11):e106447. doi: 10.1136/bmjopen-2025-106447.

Reference Type DERIVED
PMID: 41218945 (View on PubMed)

Other Identifiers

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FW-YX-001

Identifier Type: -

Identifier Source: org_study_id

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