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Enrolling by Invitation

NCT Number: NCT07141420

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

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.

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Key information

Conditions

Post-Intensive Care Syndrome postintensive care syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Routine Care

Behavioral

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

Behavioral

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

Behavioral

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 .

Primary outcomes

  1. Change in Post-Intensive Care Syndrome (PICS) Symptom Severity

    Time frame: Measured at baseline (pre-discharge), 1 month, 3 months, and 6 months post-discharge.

    • Total score of the Chinese Version of the Post-Intensive Care Syndrome Questionnaire (PICSQ).

    Domains: Physical function (6 items), cognitive impairment (6 items), psychological symptoms (6 items).

    Scoring: 18 items × 0-3 points = 0-54 total; higher scores = worse symptoms.

    • Total score of the Pittsburgh Sleep Quality Index (PSQI). Scoring: 7 components × 0-3 points = 0-21 total; higher scores = poorer sleep.
    • Recall experiences measured by the Chinese ICU Memory Tool (ICUMT). Format: 14-item mixed open/closed questions about ICU admission, treatment, and discharge memories.
    • Anxiety: GAD-7 score (0-21; higher = worse anxiety). Depression: PHQ-9 score (0-27; higher = worse depression).

Secondary outcomes

  1. Self-Management Ability

    Time frame: 1m, 3m, 6m post-discharge.

    • Total score of the Adults Health Self-Management Ability Rating Scale (AHSMSRS).

    Scoring: 38 items × 1-3 points = 38-114 total; higher scores = poorer self-management.

  2. Patient Experience with LLMs

    Time frame: 3 months and 6 months post-discharge (Group C only).

    Qualitative insights from semi-structured interviews based on the Technology Acceptance Model (TAM).

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital Of Guizhou Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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