Application of Large Language Models Techniques to Post-ICU Syndrome Management in Critically Ill Patients: A Fully Longitudinal Mixed Study
NCT ID: NCT07141420
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
90 participants
INTERVENTIONAL
2025-06-01
2026-02-20
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Routine Care Group
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, 7 days, 1/3/6 months post-discharge). No structured PICS management program or AI technology is provided.
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.
Optimized Program Group
Participants receive an evidence-based, optimized PICS management program developed using the Health Promotion Model (HPM). This includes personalized rehabilitation plans, psychological support, and education tailored to PICS symptoms. Interventions are delivered by clinical staff at discharge, 7 days, and 1/3/6 months post-discharge. No AI/LLM technology is used.
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 .
Optimized Program + LLMs Group
Participants receive the same optimized PICS program as Group B, enhanced with Large Language Models (LLMs). Key components:
Personalized AI-generated plans: ChatGPT-4 synthesizes patient data (baseline + follow-ups) to create monthly rehabilitation plans, reviewed by a multidisciplinary expert team.
LLM access: Installation of "Kimi Smart Assistant" for daily health queries. Safety protocols: Patients must validate LLM advice with nurses via WeChat before use .
Phased intervention:
Pre-discharge: LLM training + baseline plan generation.
1 month: Plan updates based on new data. 3/6 months: Plan updates + semi-structured interviews about LLM experience.
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 .
Interventions
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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 .
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
100 Years
ALL
No
Sponsors
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The Affiliated Hospital Of Guizhou Medical University
OTHER
Responsible Party
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Locations
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The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Countries
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Other Identifiers
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2024-171
Identifier Type: -
Identifier Source: org_study_id
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