LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients

Sponsor
Beijing Anzhen Hospital
Study ID
NCT07521488
Status
Not Yet Recruiting

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Conditions

  • Aortic Aneurysm
  • Aortic Dissection
  • Cardiac Surgical Procedures
  • Congenital Heart Disease
  • Coronary Artery Bypass Grafting
  • Heart Valve Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LLM-Based Intelligent Health Management Assistant — OTHER
    A 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.

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: LLM-Based Health Management Assistant Plus Standard Care
  • No Intervention: Standard Postoperative Care
    Participants receive standard postoperative clinical care and follow-up, including routine outpatient visits, standard pharmacotherapy, and conventional discharge education.

Primary Outcome Measure

Composite Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: Within 12 months after randomization ]

Central Contacts

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