Family-Participatory Early Rehabilitation in Critically Ill Patients

Hebei Medical University

Status: Completed

Conditions: Critical Illness

Treatments: Behavioral: Standard ICU Care; Behavioral: Internet-Based, Family-Participatory Early Rehabilitation (IFPER)

Study type: Interventional

Funder types: Other

Identifiers

NCT07278713

2022S00433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

Internet-Based, Family-Participatory Early Rehabilitation (IFPER) Group

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-Based, Family-Participatory Early Rehabilitation (IFPER)

Standard Care Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard ICU Care