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

Study acronym: ICURA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion pushed from Mar 31, 2026 to Jan 15, 2027
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Study completion pushed from Dec 2026 to Jan 31, 2027
    v6
  2. Notable Enrollment target: 180 to 360
    • Secondary endpoints expanded, about 9 words
    v5
  3. Notable Primary completion date: Jul 2025 to Mar 31, 2026
    • Study completion date: Aug 2026 to Dec 2026
    v4
  4. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2024 to Oct 2, 2024
    v3
  5. Notable Start date: Jul 2024 to Sep 2024v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)
Post Intensive Care Syndrome, ICU Survivors, ICU Families
Related terms postintensive care syndrome
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov