Critical Illness
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALInternet-Based, Family-Participatory Early Rehabilitation (IFPER)
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.
BEHAVIORALStandard ICU Care
Routine ICU care including medical support and standard rehabilitation delivered by ICU staff.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Efficiency | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain Scores | Through ICU stay, an average of 10 days | 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). |
| Duration of Mechanical Ventilation | Through ICU stay, an average of 7 days | The total number of days a patient requires mechanical ventilation. |
| ICU Length of Stay | Through study completion, an average of 10 days | The total number of days a patient stays in the ICU. |
| Incidence of Delirium | Through ICU stay, an average of 10 days | The percentage of patients who develop delirium, assessed twice daily using the Confusion Assessment Method for the ICU (CAM-ICU). |
| Social Stigma Score | At ICU discharge, an average of 10 days after enrollment | 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). |
| Change in Percentage of N1 Sleep | From enrollment through ICU discharge, an average of 10 days | Change in the percentage of Stage 1 non-REM sleep, measured by polysomnography (PSG). |
| Change in Percentage of N2 Sleep | From enrollment through ICU discharge, an average of 10 days | Change in the percentage of Stage 3 non-REM (slow-wave) sleep, measured by polysomnography (PSG). |
| Change in Arousal Index | From enrollment through ICU discharge, an average of 10 days | Change in the number of arousals or awakenings per hour of sleep, measured by polysomnography (PSG). |
| Change in Percentage of REM Sleep | From enrollment through ICU discharge, an average of 10 days | Change in the percentage of Rapid Eye Movement (REM) sleep, measured by polysomnography (PSG). |
Countries
China
Outcome results
None listed