Family-Participatory Early Rehabilitation in Critically Ill Patients (NCT07278713) | Clinical Trial Compass
CompletedNot Applicable
Family-Participatory Early Rehabilitation in Critically Ill Patients
China204 participantsStarted 2022-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Sleep Efficiency
Timeframe: From enrollment through ICU discharge, an average of 10 days
Trial details
NCT IDNCT07278713
SponsorThe First Hospital of Hebei Medical University