Application of Large Language Models Techniques to Post-ICU Syndrome Management in Critically Ill Patients: A Fully Longitudinal Mixed Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Post-Intensive Care Syndrome (PICS) Symptom Severity
研究概览
简要总结
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:
- Group A (routine care)
- Group B (optimized program without LLMs)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Post-Intensive Care Syndrome (PICS) Symptom Severity
时间窗: 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).
次要结局
- Self-Management Ability(1m, 3m, 6m post-discharge.)
- Patient Experience with LLMs(3 months and 6 months post-discharge (Group C only).)