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KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Completed NA INTERVENTIONAL NCT07278713

Family-Participatory Early Rehabilitation in Critically Ill Patients

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: Internet-Based, Family-Participatory Early Rehabilitation (IFPER)
Type: BEHAVIORAL
Description: 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."
Name: Standard ICU Care
Type: BEHAVIORAL
Description: Routine ICU care including medical support and standard rehabilitation delivered by ICU staff.

Primary Outcomes

Measure: Change in Sleep Efficiency
TimeFrame: From enrollment through ICU discharge, an average of 10 days
Description: 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.

Trial Information

NCT ID

NCT07278713

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

The First Hospital of Hebei Medical University

Last Updated

December 15, 2025