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NCT Number: NCT07273513

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabete Mellitus Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Post CABG Post PCI Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smart family doctor

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 manager

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

Behavioral

Participants will receive usual secondary prevention management.

Primary outcomes

  1. The control rates of hypertension, diabetes and hyperlipidemia

    Time frame: 6-month

    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.

Secondary outcomes

  1. Blood Pressure Control Rate

    Time frame: 6-month

    The proportion of patients with systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg.

  2. Blood glucose Control Rate

    Time frame: 6-month

    The proportion of patients with HbA1c less than 7%.

  3. Blood lipid Control Rate

    Time frame: 6-month

    The proportion of patients with LDL-C less than 1.4mmol/L.

  4. Systolic blood pressure

    Time frame: 6-month

    Systolic blood pressure measured at the local site.

  5. Diastolic blood pressure

    Time frame: 6-month

    Diastolic blood pressure measured at the local site.

  6. Fasting blood glucose

    Time frame: 6-month

    Fasting blood glucose analyzed at central lab.

  7. HbA1c

    Time frame: 6-month

    HbA1c analyzed at central lab.

  8. Total cholesterol

    Time frame: 6-month

    Total cholesterol analyzed at central lab.

  9. LDL-C

    Time frame: 6-month

    LDL-C analyzed at central lab.

  10. HDL-C

    Time frame: 6-month

    HDL-C analyzed at central lab.

  11. Triglycerides

    Time frame: 6-month

    Triglycerides analyzed at central lab.

  12. Medication adherence (4-item Morisky Medication-Taking Adherence Scale)

    Time frame: 6-month

    Medication adherence measured by MMAS-4. The score range from 0 to 4. The higher score indicated the better medication adherence.

  13. Coronary artery disease-related quality of life (the Seattle Angina Questionnaire)

    Time frame: 6-month

    Coronary artery disease-related quality of life assessed with the Seattle Angina Questionnaire (SAQ). The score range from 0 to 100. The higher score indicated the better coronary artery disease-related quality of life.

  14. Smoking Rate

    Time frame: 6-month

    The proportion of patients who have smoked within the past month.

Other outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: 6-month

    The composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization due to cardiovascular disease.

  2. BMI

    Time frame: 6-month

    Body mass index (BMI) is calculated as weights (kg) divided by the square of heights (meters).

  3. Waist circumference

    Time frame: 6-month

    Waist circumference is measured at local site.

  4. Rehospitalization rate

    Time frame: 6-month

    The proportion of patients who had hospitalization

  5. The number of emergency visit

    Time frame: 6-month

    The number of emergency visit during follow-up period

  6. System usability (system usability scale)

    Time frame: 6-month

    System usability measured by system usability scale. The proportion of patients who scaled system usability more than 68 points.

  7. Subgroup-age

    Time frame: 6-month

    Primary outcome analyses in age subgroups: <=65, >65 years

  8. Subgroup-sex

    Time frame: 6-month

    Primary outcome analyses in sex subgroups: women, men

  9. Subgroup-education level

    Time frame: 6-month

    Primary outcome analyses in education level subgroups: less than high school, high school or higher

  10. Subgroup-smoking status

    Time frame: 6-month

    Primary outcome analyses in smoking status subgroups: current smoking, no smoking

  11. Subgroup-baseline BP level

    Time frame: 6-month

    Primary outcome analyses in baseline BP level subgroups: SBP/DBP>=130/80 mmHg, <130/80 mmHg

  12. Subgroup-baseline LDL-C level

    Time frame: 6-month

    Primary outcome analyses in baseline LDL-C level subgroups: <1.4 mmolL, >=1.4 mmol/L

  13. Subgroup-baseline HbA1c level

    Time frame: 6-month

    Primary outcome analyses in baseline HbA1c level subgroups: <7%, >=7%

Study contacts

Contact information is provided by the study sponsor or research team.

Lihua Zhang, PhD

CONTACT

[email protected]

8601060866780

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Acronym: SMART II

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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