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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
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-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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

History of CABG surgery or PCI with history of 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

    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

    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.

Treatment groups

536 Participants
are divided into 2 treatment groups
Group A: "Smart family doctor" assisted management plus health managersExperimental treatment 2 interventions
Group B: Usual care: health managersPlacebo 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

Smoking Rate

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

Time frame
6-month
3

Total cholesterol

Total cholesterol analyzed at central lab.

Time frame
6-month
4

LDL-C

LDL-C analyzed at central lab.

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

C-reactive protein

C-reactive protein (CRP) analyzed at central lab.

Time frame
6-month
3

interleukin-6

Interleukin-6 (IL-6) is analyzed at central lab.

Time frame
6-month
4

Interleukin-10

Interleukin-10 (IL-10) is analyzed at central lab.

Time frame
6-month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator