Family-Participatory Early Rehabilitation in Critically Ill Patients

NCT ID: NCT07278713

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-07-01

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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."

Standard Care Group

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.

Group Type: ACTIVE_COMPARATOR

Standard ICU Care

Intervention Type: BEHAVIORAL

Routine ICU care including medical support and standard rehabilitation delivered by ICU staff.

Interventions

Internet-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."

Intervention Type: BEHAVIORAL

Standard ICU Care

Routine ICU care including medical support and standard rehabilitation delivered by ICU staff.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qiao Ke

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2022S00433

Identifier Type: -

Identifier Source: org_study_id