Family-Participatory Early Rehabilitation in Critically Ill Patients

Effect of an Internet-Based, Mobile Terminal-Supported, Family-Participatory Early Rehabilitation Model on Sleep Improvement and Stigma Prevention in Critically Ill Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Behavioral: Internet-Based, Family-Participatory Early Rehabilitation (IFPER); Behavioral: Standard ICU Care

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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The First Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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."
Active Comparator: 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.	Behavioral: Standard ICU Care; Routine ICU care including medical support and standard rehabilitation delivered by ICU staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The First Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: 2022S00433

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No