Clinical trial NCT06615609: "Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients
Official title: "Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Coronary Artery Bypass Grafting
Hypertension
Diabetes Mellitus
Hyperlipidemia
Keywords: smartphone
AI-assisted
CABG management
metabolic management
Smart family doctor
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2024-09-26
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention in this study is the implementation of the 'Smart family doctor' system, a digital health management tool designed to support secondary prevention in post-CABG patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-CABG issues. It is powered by a large-scale, medical knowledge-enhanced conversational model, enabling personalized interactions with patients to guide their recovery and lifestyle management following surgery.
Primary purpose: TREATMENT

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. 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 patients with hypertension, diabetes, and dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* History of CABG surgery 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 1.8 mmol/L
* Use of a smartphone.
* 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.

Primary outcomes:
measure: The control rates of hypertension, diabetes and hyperlipidemia
timeFrame: 6-month
Secondary outcomes:
measure: Blood Pressure Control Rate
timeFrame: 6-month
measure: Smoking Rate
timeFrame: 6-month
measure: Total cholesterol
timeFrame: 6-month
measure: LDL-C
timeFrame: 6-month
measure: HDL-C
timeFrame: 6-month
measure: Triglycerides
timeFrame: 6-month
measure: Small dense LDL-C
timeFrame: 6-month
measure: Lipoprotein (a)
timeFrame: 6-month
measure: Fasting blood glucose
timeFrame: 6-month
measure: HbA1c
timeFrame: 6-month
measure: Physical Activity Level
timeFrame: 6-month
measure: Quality of Life
timeFrame: 6-month
measure: Coronary artery disease-related quality of life
timeFrame: 6-month
measure: Psychological status
timeFrame: 6-month
measure: Cognitive function
timeFrame: 6-month
Other outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 6-month
measure: C-reactive protein
timeFrame: 6-month
measure: interleukin-6
timeFrame: 6-month
measure: Interleukin-10
timeFrame: 6-month
measure: Interleukin-1β (IL-1β)
timeFrame: 6-month
measure: tumor necrosis factor-α (TNF-α)
timeFrame: 6-month
measure: prostaglandin
timeFrame: 6-month
measure: Intercellular adhesion molecule-1
timeFrame: 6-month
measure: Von Willebrand factor
timeFrame: 6-month
measure: Urinary albumin-to-creatinine ratio
timeFrame: 6-month
measure: Urinary sodium excretion rate
timeFrame: 6-month
measure: BMI
timeFrame: 6-month
measure: Waist circumference
timeFrame: 6-month
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xin Yuan, PhD
role: PRINCIPAL_INVESTIGATOR
References: