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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-Based, Family-Participatory Early Rehabilitation (IFPER) Group | Experimental | In addition to standard care, patients received a structured, family-participatory early rehabilitation program guided by the "7P Rehabilitation Pyramid Model." Trained family members used a mobile application to assist with activities including Position Management, Pain & Sedation Management, Physiotherapeutics, Pulmonary Rehabilitation, Psychological Rehabilitation, Performance Rebuilding, and fostering Purpose & Belonging. The sessions were conducted for 30-45 minutes, twice daily. |
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| Standard Care Group | Active Comparator | Patients received routine ICU care, which included standard medical and supportive care, daily assessments, sedation management, pain control, nutritional support, and standard early rehabilitation protocols delivered by the ICU physical therapy team. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based, Family-Participatory Early Rehabilitation (IFPER) | Behavioral | A structured, multi-component rehabilitation program facilitated by trained family members using a mobile application for guidance and communication, based on the "7P Rehabilitation Model." |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Efficiency | 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. | From enrollment through ICU discharge, an average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Social Stigma Score | Measured by the Social Stigma in Critical Illness (SSCI) scale. The scale ranges from 10 to 50. A higher score indicates a worse outcome (greater perceived stigma). | At ICU discharge, an average of 10 days after enrollment |
| Procedural Pain Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard ICU Care | Behavioral | Routine ICU care including medical support and standard rehabilitation delivered by ICU staff. |
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Assessed daily using the Numeric Rating Scale (NRS) for communicative patients and the Critical-Care Pain Observation Tool (CPOT) for non-communicative patients. The NRS is on a 0-10 scale, and the CPOT is on a 0-8 scale. For both scales, a higher score indicates a worse outcome (more pain). |
| Through ICU stay, an average of 10 days |
| Duration of Mechanical Ventilation | The total number of days a patient requires mechanical ventilation. | Through ICU stay, an average of 7 days |
| ICU Length of Stay | The total number of days a patient stays in the ICU. | Through study completion, an average of 10 days |
| Incidence of Delirium | The percentage of patients who develop delirium, assessed twice daily using the Confusion Assessment Method for the ICU (CAM-ICU). | Through ICU stay, an average of 10 days |
| Change in Percentage of REM Sleep | Change in the percentage of Rapid Eye Movement (REM) sleep, measured by polysomnography (PSG). | From enrollment through ICU discharge, an average of 10 days |
| Change in Percentage of N1 Sleep | Change in the percentage of Stage 1 non-REM sleep, measured by polysomnography (PSG). | From enrollment through ICU discharge, an average of 10 days |
| Change in Percentage of N2 Sleep | Change in the percentage of Stage 3 non-REM (slow-wave) sleep, measured by polysomnography (PSG). | From enrollment through ICU discharge, an average of 10 days |
| Change in Arousal Index | Change in the number of arousals or awakenings per hour of sleep, measured by polysomnography (PSG). | From enrollment through ICU discharge, an average of 10 days |