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Clinical Trials in China / NCT07141420
Enrolling by invitation Not applicable

Application of Large Language Models Techniques to Post-ICU Syndrome Management in Critically Ill Patients: A Fully Longitudinal Mixed Study

NCT07141420 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Hospital Of Guizhou Medical University
Phase
Not applicable
Started
2025-06-01
Last updated
2025-08-26

Condition(s) studied

Post-Intensive Care Syndrome

Investigational drug(s) / intervention(s)

Routine CareHealth Promotion Model-Based Optimized ProgramLLM-Enhanced Optimized Program

Routine Care: Participants receive standard post-ICU follow-up care according to hospital protocols . This includes routine health assessments and general rehabilitation guidance at designated intervals (discharge, 1/3/6 months post-discharge). No structured PICS management program or AI technology is provided.

Health Promotion Model-Based Optimized Program: An evidence-based, multidisciplinary rehabilitation protocol for Post-Intensive Care Syndrome (PICS) management, developed using the Health Promotion Model (HPM). It includes: Personalized rehabilitation plans addressing physical, cognitive, and psychological recovery. Structured follow-up at discharge, 1/3/6 months post-discharge. Components: Physical function training, cognitive exercises, anxiety/depression coping strategies, and sleep hygiene education. Delivery: Clinician-guided (no AI/technology involved). Developed via literature review and validated by ICU physicians and nursing experts .

LLM-Enhanced Optimized Program: Combines the HPM-Based Optimized Program with Large Language Model (LLM) technology for dynamic personalization: AI-generated rehabilitation plans: ChatGPT-4 synthesizes patient data (baseline + follow-ups) to create/update monthly plans, reviewed by a multidisciplinary expert team. Patient-facing LLM tool: "Kimi Smart Assistant" installed for daily health queries under strict safety protocols (all outputs validated by nurses via WeChat). Phased implementation: Pre-discharge: LLM training + baseline plan generation. 1/3/6 months: Plan updates + outcome tracking. 3/6 months: Semi-structured interviews on LLM experience. Includes LLM usage guidelines and expert validation safeguards .

Study summary

The goal of this clinical trial is to evaluate whether Large Language Models (LLMs) combined with an optimized care program can effectively manage Post-Intensive Care Syndrome (PICS) in adult ICU survivors (aged ≥18 years) discharged from a tertiary hospital in China. The main questions it aims to answer are:

* Does the intervention (optimized program + LLMs) improve physical, psychological, cognitive, and social function recovery compared to standard care or the optimized program alone?
* How do patients experience and perceive the utility of LLMs in PICS self-management during recovery?

Researchers will compare three groups:

1. Group A (routine care)
2. Group B (optimized program without LLMs)
3. Group C (optimized program + LLMs) to see if adding LLMs significantly enhances PICS symptom management, patient self-efficacy, and quality of life over 6 months post-discharge.

Participants will:

* Install and use the Kimi Smart Assistant LLM (Group C only) for health queries under nurse supervision.
* Complete standardized questionnaires at discharge (baseline), 7 days, 1 month, 3 months, and 6 months post-discharge:

* PICS Symptom Questionnaire (PICSQ)
* Pittsburgh Sleep Quality Index (PSQI)
* Anxiety (GAD-7) and Depression (PHQ-9) scales
* Self-Management Ability Scale (AHSMSRS)
* Attend semi-structured interviews (Group C only) at 3 and 6 months to share experiences with LLM use.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * ICU hospitalization duration \> 24 hours. * Age ≥ 18 years. * Conscious at ICU discharge, able to communicate without barriers. * Provide informed consent to participate. * Regular access to and usage of smart electronic devices. Exclusion Criteria: * Previous ICU admission (≥24h) within 3 months before the current hospitalization. * Transferred to another ICU during the current hospitalization. * Pre-existing cognitive impairment (Blessed Dementia Rating Scale \[BDRS\] score \>4 before ICU admission). * Severe communication barriers: Hearing impairment Dysarthria Other conditions preventing follow-up assessments. * Critically unstable condition preventing questionnaire completion. * Infrequent/no experience using smart electronic devices (e.g., smartphones, tablets).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou

More The Affiliated Hospital Of Guizhou Medical University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07141420 on ClinicalTrials.gov ↗ ← All trials in China