Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07141420
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-26
First Post:
2025-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Large Language Models Techniques to Post-ICU Syndrome Management in Critically Ill Patients: A Fully Longitudinal Mixed Study
Sponsor:
The Affiliated Hospital Of Guizhou Medical University
Organization:
Study Overview
Official Title:
Application of Large Language Models Techniques to Post-ICU Syndrome Management in Critically Ill Patients: A Fully Longitudinal Mixed Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: