Clinical Trial

The Post Intensive Care Syndrome Follow-up and Management Study: The ICU Recovery Answers Project

Study acronym: ICURA
Active, Not Recruiting
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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.
Protocol Amendment History 3 changes
critical Trial status changed: Enrolling by Invitation → Active, Not Recruiting 2026-05-28
notable Primary completion pushed: 2026-03-31 -> 2027-01-15 2026-05-28
minor Completion pushed: 2026-12 -> 2027-01-31 2026-05-28
Trial Details
NCT Number NCT06504979
Lead Sponsor Corporacion Parc Tauli
Collaborators: Universitat de les Illes Balears, Hospital Son Espases, Fundació La Marató de TV3
Conditions Post Intensive Care Syndrome, ICU Survivors, ICU Families
Enrollment 360 participants
Start Date 2024-10-02
Primary Completion 2027-01-15 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-27