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Clinical Trials in Spain / NCT06504979
Active, not recruiting Not applicable

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

NCT06504979 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-10-02
Last updated
2026-05-27

Condition(s) studied

Post Intensive Care SyndromeICU SurvivorsICU Families

Investigational drug(s) / intervention(s)

Telehealth follow-up of post-intensive care syndrome

Telehealth follow-up of post-intensive care syndrome: Using a telehealth platform for the detection of the emotional, neuropsychological and physical PICS-related sequelae along 12 months in ICU survivors

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
89 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institut d'Investigació i Innovació Parc Taulí Sabadell Barcelona

More Corporacion Parc Tauli trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06504979 on ClinicalTrials.gov ↗ ← All trials in Spain