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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years.

Underwent CABG or PCI more than 3 months prior and have concurrent hypertension, diabetes, and dyslipidemia.

Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg

HbA1c no less than 7%

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

951 Participants
are divided into 3 treatment groups
Group A: "Smart family doctor" assisted managementExperimental treatment 1 intervention
Group B: Health managersExperimental treatment 1 intervention
Group C: Usual carePlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6-month

Secondary outcomes

1

Blood Pressure Control Rate

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

Time frame
6-month
2

Blood glucose Control Rate

The proportion of patients with HbA1c less than 7%.

Time frame
6-month
3

Blood lipid Control Rate

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

Time frame
6-month
4

Systolic blood pressure

Systolic blood pressure measured at the local site.

Time frame
6-month

Other outcomes

1

Major adverse cardiovascular events (MACE)

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

Time frame
6-month
2

BMI

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

Time frame
6-month
3

Waist circumference

Waist circumference is measured at local site.

Time frame
6-month
4

Rehospitalization rate

The proportion of patients who had hospitalization

Time frame
6-month

Locations

This trial has no locations.

Sponsors and contacts

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