The Post Intensive Care Syndrome Follow-up and Management Study: The ICU Recovery Answers Project (NCT06504979) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Post Intensive Care Syndrome Follow-up and Management Study: The ICU Recovery Answers Project
Spain360 participantsStarted 2024-10-02
Plain-language summary
Critically ill survivors develop mental health, cognition, and mobility sequelae known as Post-Intensive Care Syndrome (PICS). Clinically significant symptoms of post-traumatic stress, depression, anxiety, and cognitive impairment are frequently observed at short- and long-term after ICU, impacting quality of life of the survivors and their relatives.
The main objective of the project is to optimize, implement and evaluate the impact in quality of life of a digital platform (ICURA) specifically designed for following-up and managing the mental health sequelae related to PICS in ICU survivors and their relatives during the one-year recovery phase.
Methods: Observational, prospective and multicenter study including two cohorts: 1) ICU patients' cohort (ICUcohort), and 2) ICU patients' family cohort (ICU-F-cohort). After ICU discharge, patients will be randomized to participate in a follow-up with ICURA vs. the standard follow-up.
Expected results: Critically ill survivors in the APPICS program after ICU will show better levels of functionality and quality of life than those participants in the usual follow-up. APPICS will contribute to enhancing the prognosis of emotional alterations during the 12 months after ICU both, in ICU survivors, and relatives. Analyzing risk factors, based on demographic and clinical data, will help to the early detection of long-term mental health difficulties in ICU survivors.
Who can participate
Age range
18 Years – 89 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:
* Adult (≥18 years old) critically ill patients admitted to the ICU with or without need of invasive mechanical ventilation (IMV).
Exclusion Criteria:
* Non-authorization of the relatives and/or patient to inclusion in the study; neurocritical ICU patients.
* Severe neurological pathology (including dementia or focal brain damage with functional and cognitive impairment) prior to admission to the ICU.
* Severe psychiatric pathology (schizophrenia, bipolar disorder, major depressive disorder)
* Intellectual disability (IQ \<80).
* Patients who develop secondary complications (infections, stroke, TBI or any non-transient acquired brain damage) after ICU discharge, that may compromise the results of the emotional and neuropsychological evaluation during the recovery phase
* Moderate-severe cognitive impairment (Short-IQCODE \>85) that impair ICU patients an independent participation in the telematic follow up and accompaniment program
* Readmission to ICU within 12 months after discharge from ICU
* Idiomatic barrier (non spanish and/or catalan speaker)
* Patients with life expectancy \<1 year or not subsidiaries of active treatment measures.
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.
1This study is focused on Post Intensive Care Syndrome — could you explain whether the problems I've been experiencing since leaving the ICU, like physical weakness, memory issues, or anxiety, might actually be PICS, and if so, how this study's follow-up approach could help address them?
2Since this trial is no longer actively recruiting new participants, is there still any way for me to access the ICU recovery support or follow-up services being studied here, or are there similar programs at this hospital that could help me?
3The study is measuring health-related quality of life and functionality in ICU survivors — based on where I am right now in my recovery, what does my doctor think my biggest barriers to regaining normal function actually are, and what care exists outside of this trial to help me?
4I've heard that family members of ICU patients can also be affected by PICS — should my family members be evaluated too, and what resources are available for them whether or not we can connect to this specific study?
5Since this is listed as a non-interventional study with no specific phase, does that mean it's mainly observational and not testing a new treatment, and if so, what treatment options does my doctor recommend I actively pursue for my PICS symptoms right now?
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.