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

NCT07521488 | Not Yet Recruiting DMC

• 1 other identifier: cFT-LLM-2026-001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Large Language Model; Artificial Intelligence; Cardiac Surgery; Postoperative Health Management; Digital Health; Medication Adherence; Cardiac Rehabilitation; MACCE; Mobile Health Application; Personalized Health Management

Outcome Measures

Primary Outcomes (1)

• 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).

  Within 12 months after randomization

Secondary Outcomes (7)

• Change in Health-Related Quality of Life Assessed by the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score

  Baseline and 12 months after randomization

• Change in Health Status Assessed by the European Quality of Life Visual Analogue Scale (EQ-VAS)

  Baseline and 12 months after randomization

• Cardiovascular Rehospitalization Rate

  Within 12 months after randomization

• Change in Medication Adherence Assessed by the 8-Item Morisky Medication Adherence Scale (MMAS-8)

  Baseline and 12 months after randomization

• Time in Therapeutic INR Range (TTR) Among Anticoagulated Participants

  Within 12 months after randomization

Study Arms (2)

LLM-Based Health Management Assistant Plus Standard Care

EXPERIMENTAL

Other: LLM-Based Intelligent Health Management Assistant

Standard Postoperative Care

NO INTERVENTION

Participants receive standard postoperative clinical care and follow-up, including routine outpatient visits, standard pharmacotherapy, and conventional discharge education.

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.

LLM-Based Health Management Assistant Plus Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Voluntarily participates in the study, understands and signs the informed consent form, and is able to comply with the study protocol requirements

You may not qualify if:

• 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
• Currently participating in another interventional clinical study
• Anticipated inability to complete 12-month follow-up

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Aneurysm; Aortic Dissection; Heart Defects, Congenital; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aneurysm; Vascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ming Gong, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Gong, MD

CONTACT

+86 13901212470; gongming@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)