This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health management of patients after cardiac surgery. A total of 500 adult patients who undergo cardiac surgery (including coronary artery bypass grafting, heart valve surgery, great vessel surgery, congenital heart disease correction, and other cardiac procedures) at Beijing Anzhen Hospital will be randomly assigned in a 1:1 ratio to an intervention group or a control group, stratified by age (\<65 vs ≥65 years) and surgery type. The intervention group will use the LLM-based mobile health management application in addition to standard postoperative care, while the control group will receive standard postoperative care alone. The application integrates multimodal clinical data into a personalized health profile and provides surgery-type-specific postoperative management recommendations, medication adherence reminders, complication early warning, and cardiac rehabilitation guidance. The primary outcome is the composite endpoint of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke, or unplanned cardiovascular reoperation/reintervention, within 12 months after randomization. Secondary outcomes include health-related quality of life (EQ-5D-5L), cardiovascular rehospitalization rate, medication adherence (MMAS-8), postoperative complication rate, and cardiac rehabilitation achievement rate. Follow-up visits are scheduled at 1, 3, 6, 9, and 12 months post-randomization.
Aged 18 years or older, any sex
Underwent cardiac surgery at the Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, including but not limited to: coronary artery bypass grafting (CABG), heart valve replacement or repair (aortic valve, mitral valve, or tricuspid valve surgery), great vessel surgery (aortic dissection or aortic aneurysm repair), congenital heart disease correction, or cardiac assist device implantation
Clinically stable after surgery and eligible for hospital discharge
Has access to a smartphone and is capable of independently operating a mobile application, or has a family member available to assist with operation
Postoperative intensive care unit (ICU) stay exceeding 30 days, or presence of severe uncontrolled postoperative complications such as persistent infection or multi-organ failure
Life expectancy less than 12 months due to advanced malignancy or end-stage organ failure
Severe cognitive impairment, psychiatric disorder, or inability to understand and use a mobile application without available caregiver assistance
Heart transplant recipient
Parallel
LLM-Based Intelligent Health Management Assistant
Other interventionA mobile application integrating large language model technology with individual health records. Participants upload multimodal clinical data including medical records, laboratory results, imaging data, and treatment histories to build a structured personal health profile. The assistant periodically incorporates the latest clinical practice guidelines and provides personalized lifestyle intervention recommendations, medication adherence reminders, and early warnings for potential health-critical events, in addition to standard clinical care.
Composite Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Composite endpoint defined as the first occurrence of any of the following: all-cause death, non-fatal myocardial infarction (per the Fourth Universal Definition of Myocardial Infarction), non-fatal stroke (imaging-confirmed ischemic or hemorrhagic), or unplanned cardiovascular reoperation/reintervention (including unplanned cardiac reoperation, percutaneous coronary intervention, transcatheter valve intervention, or other cardiovascular interventional procedures).
Change in Health-Related Quality of Life Assessed by the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score
Change from baseline to 12 months in the EQ-5D-5L index score. The EQ-5D-5L index score ranges from -0.391 to 1.000 (using the Chinese value set), where higher scores indicate better health-related quality of life.
Change in Health Status Assessed by the European Quality of Life Visual Analogue Scale (EQ-VAS)
Change from baseline to 12 months in the EQ-VAS score. The EQ-VAS records self-rated health on a vertical visual analogue scale ranging from 0 to 100, where 0 represents the worst health the patient can imagine and 100 represents the best health the patient can imagine. Higher scores indicate better self-rated health.
Cardiovascular Rehospitalization Rate
Proportion of participants rehospitalized for cardiovascular causes and total number of cardiovascular rehospitalizations within 12 months after randomization.
Change in Medication Adherence Assessed by the 8-Item Morisky Medication Adherence Scale (MMAS-8)
Change from baseline to 12 months in the MMAS-8 score. The MMAS-8 score ranges from 0 to 8, where higher scores indicate better medication adherence. Scores are categorized as high adherence (score of 8), medium adherence (score of 6 to \<8), and low adherence (score of \<6).
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