Application of Large Language Model-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Patients After Cardiac Surgery: A Prospective Randomized Controlled Study
Trial ID: NCT07521488
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-05-01
Completion date: 2027-12-31
Sponsor: Beijing Anzhen Hospital
Conditions: Coronary Artery Bypass Grafting; Heart Valve Disease; Aortic Aneurysm; Aortic Dissection; Congenital Heart Disease; Cardiac Surgical Procedures
Interventions: LLM-Based Intelligent Health Management Assistant
Locations: Beijing Anzhen Hospital, Capital Medical University
Countries: China
Enrollment: 500
Age range: 18 Years - None
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

1. Aged 18 years or older, any sex
2. 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
3. Clinically stable after surgery and eligible for hospital discharge
4. Has access to a smartphone and is capable of independently operating a mobile application, or has a family member available to assist with operation
5. Voluntarily participates in the study, understands and signs the informed consent form, and is able to comply with the study protocol requirements

Exclusion Criteria:

1. Postoperative intensive care unit (ICU) stay exceeding 30 days, or presence of severe uncontrolled postoperative complications such as persistent infection or multi-organ failure
2. Life expectancy less than 12 months due to advanced malignancy or end-stage organ failure
3. Severe cognitive impairment, psychiatric disorder, or inability to understand and use a mobile application without available caregiver assistance
4. Heart transplant recipient
5. Currently participating in another interventional clinical study
6. Anticipated inability to complete 12-month follow-up

Outcomes:
Composite Major Adverse Cardiac and Cerebrovascular Events (MACCE)