Family-Participatory Early Rehabilitation in Critically Ill Patients

NCT07278713 | Completed

• 1 other identifier: 2022S00433
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

• ICU Length of Stay

  Through study completion, an average of 10 days

• Incidence of Delirium

  Through ICU stay, an average of 10 days

Study Arms (2)

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.

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

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.

Behavioral: Standard ICU Care

Interventions

Standard ICU Care BEHAVIORAL

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

Standard Care Group

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."

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 12, 2025
• Study Start: July 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-11

Locations

CN (1)