Effect of an Internet-Based, Mobile Terminal-Supported, Family-Participatory Early Rehabilitation Model on Sleep Improvement and Stigma Prevention in Critically Ill Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Change in Sleep Efficiency
研究概览
简要总结
This prospective, randomized controlled trial aims to evaluate the efficacy of an Internet-Based, Family-Participatory Early Rehabilitation (IFPER) model compared to standard care for critically ill patients in the Intensive Care Unit (ICU). The study will determine if the IFPER model, which is based on a structured "7P Rehabilitation" framework, can improve sleep quality, reduce the perception of critical illness-related social stigma, and alleviate procedural pain.
详细描述
Critically ill patients often suffer from Post-Intensive Care Syndrome (PICS), which includes severe sleep disturbances, pain, and psychological issues like social stigma. While family involvement in care is known to be beneficial, structured, technology-supported models are scarce. This study was designed to address this gap by testing a novel IFPER model. A total of 204 adult patients admitted to the ICU were randomized to either the IFPER group or a standard care group. The IFPER intervention involves trained family members using a mobile application to deliver a structured, multi-component rehabilitation program based on the "7P Rehabilitation Model" (Position Management, Pain & Sedation, Physiotherapeutics, Pulmonary Rehabilitation, Psychological Rehabilitation, Performance Rebuilding, Purpose & Belonging). The standard care group received routine ICU care. The study hypothesizes that this structured, family-centered approach will lead to significantly better outcomes in sleep, stigma perception, and pain management compared to standard care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Expected ICU stay of more than 48 hours
- •Hemodynamic stability (mean arterial pressure 65-110 mmHg with no or low-dose vasopressor support)
- •Stable respiratory status (PaO2/FiO2 > 200 mmHg, SpO2 ≥ 88%)
- •Richmond Agitation-Sedation Scale (RASS) score ≥ -2
- •Having at least one family member willing and able to participate
排除标准
- •Unstable cardiovascular conditions (e.g., acute coronary syndrome, malignant arrhythmia)
- •Acute neurological injury with unstable intracranial pressure
- •Unstable fractures or spinal cord injury
- •Active, uncontrolled bleeding
- •Pre-existing severe psychiatric disorders or dementia
- •Inability to provide consent and no available legal surrogate
结局指标
主要结局
Change in Sleep Efficiency
时间窗: From enrollment through ICU discharge, an average of 10 days
Measured by polysomnography (PSG). Sleep efficiency is calculated as (total sleep time / time in bed) × 100%. The change is assessed from baseline to the day before ICU discharge.
次要结局
- ICU Length of Stay(Through study completion, an average of 10 days)
- Social Stigma Score(At ICU discharge, an average of 10 days after enrollment)
- Procedural Pain Scores(Through ICU stay, an average of 10 days)
- Duration of Mechanical Ventilation(Through ICU stay, an average of 7 days)
- Incidence of Delirium(Through ICU stay, an average of 10 days)
- Change in Percentage of N1 Sleep(From enrollment through ICU discharge, an average of 10 days)
- Change in Percentage of N2 Sleep(From enrollment through ICU discharge, an average of 10 days)
- Change in Percentage of REM Sleep(From enrollment through ICU discharge, an average of 10 days)
- Change in Arousal Index(From enrollment through ICU discharge, an average of 10 days)
研究者
Qiao Ke
Principal investigator
The First Hospital of Hebei Medical University