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Набор по приглашению NCT07141420

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

Без фазы С лечением Post-Intensive Care Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Routine Care, Health Promotion Model-Based Optimized Program, LLM-Enhanced Optimized Program.
Кому может быть актуально
Состояния в реестре: Post-Intensive Care Syndrome. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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/t
  • Поведенческое 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 +

Первичные конечные точки

  • Change in Post-Intensive Care Syndrome (PICS) Symptom Severity [Срок оценки: Measured at baseline (pre-discharge), 1 month, 3 months, and 6 months post-discharge.]
Вторичные конечные точки (2)
  • Self-Management Ability [Срок оценки: 1m, 3m, 6m post-discharge.]
  • Patient Experience with LLMs [Срок оценки: 3 months and 6 months post-discharge (Group C only).]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Китай · 1 центр
  • The Affiliated Hospital of Guizhou Medical University — Guiyang

Идентификаторы

NCT: NCT07141420 · 2024-171

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗