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NCT Number: NCT07278713

Family-Participatory Early Rehabilitation in Critically Ill Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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."

Standard ICU Care

Behavioral

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

Primary outcomes

  1. Change in Sleep Efficiency

    Time frame: 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 outcomes

  1. Social Stigma Score

    Time frame: 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).

  2. Procedural Pain Scores

    Time frame: 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).

  3. Duration of Mechanical Ventilation

    Time frame: Through ICU stay, an average of 7 days

    The total number of days a patient requires mechanical ventilation.

  4. ICU Length of Stay

    Time frame: Through study completion, an average of 10 days

    The total number of days a patient stays in the ICU.

  5. Incidence of Delirium

    Time frame: 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).

  6. Change in Percentage of REM Sleep

    Time frame: From enrollment through ICU discharge, an average of 10 days

    Change in the percentage of Rapid Eye Movement (REM) sleep, measured by polysomnography (PSG).

  7. Change in Percentage of N1 Sleep

    Time frame: From enrollment through ICU discharge, an average of 10 days

    Change in the percentage of Stage 1 non-REM sleep, measured by polysomnography (PSG).

  8. Change in Percentage of N2 Sleep

    Time frame: 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).

  9. Change in Arousal Index

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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