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Not yet recruiting NCT07273513

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

No phase Interventional Hypertension Diabete Mellitus Hyperlipidemia Post PCI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smart family doctor, Health manager, Usual Care.
Who it may be relevant to
Registry conditions: Hypertension, Diabete Mellitus, Hyperlipidemia, Post PCI. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral Smart family doctor
    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
  • 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.
  • Behavioral Usual Care
    Participants will receive usual secondary prevention management.

Primary outcome measures

  • The control rates of hypertension, diabetes and hyperlipidemia [Time frame: 6-month]
Secondary outcome measures (12)
  • Blood Pressure Control Rate [Time frame: 6-month]
  • Blood glucose Control Rate [Time frame: 6-month]
  • Blood lipid Control Rate [Time frame: 6-month]
  • Systolic blood pressure [Time frame: 6-month]
  • Diastolic blood pressure [Time frame: 6-month]
  • Fasting blood glucose [Time frame: 6-month]
  • HbA1c [Time frame: 6-month]
  • Total cholesterol [Time frame: 6-month]
  • LDL-C [Time frame: 6-month]
  • HDL-C [Time frame: 6-month]
  • Triglycerides [Time frame: 6-month]
  • Medication adherence (4-item Morisky Medication-Taking Adherence Scale) [Time frame: 6-month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07273513 · FW-YX-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗