"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients or Post Percutaneous Coronary Intervention Patients
SMART
1 other identifier
interventional
536
1 country
1
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2024
CompletedFirst Posted
Study publicly available on registry
September 26, 2024
CompletedStudy Start
First participant enrolled
September 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2026
December 8, 2025
December 1, 2025
12 months
September 21, 2024
December 2, 2025
Conditions
Keywords
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 (15)
Blood Pressure Control Rate
6-month
Smoking Rate
6-month
Total cholesterol
6-month
LDL-C
6-month
HDL-C
6-month
- +10 more secondary outcomes
Other Outcomes (14)
Major adverse cardiovascular events (MACE)
6-month
C-reactive protein
6-month
interleukin-6
6-month
- +11 more other outcomes
Study Arms (2)
"Smart family doctor" assisted management plus health managers
EXPERIMENTAL"Smart family doctor", an AI-assisted applications with personalized interactions and 3-hour health management guidance from a health manager once a week.
Usual care: health managers
PLACEBO COMPARATOR3-hour health management guidance from a health manager once a week.
Interventions
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.
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'.
Eligibility Criteria
You may qualify if:
- 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinjiang's First Affiliated Hospital of medical university
Ürümqi, Xinjiang, 102300, China
Related Publications (1)
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.
PMID: 41218945DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Yuan, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
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
Study Record Dates
First Submitted
September 21, 2024
First Posted
September 26, 2024
Study Start
September 24, 2025
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
November 15, 2026
Last Updated
December 8, 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 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.
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 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.