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

Implementation of a Digital Tool for the Telematic Follow-up and Management of Emotional and Cognitive Sequelae Related to Post-intensive Care Syndrome: Impact on Quality of Life and Functionality

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post Intensive Care Syndrome; ICU Survivors; ICU Families
• Intervention / Treatment: Other: Telehealth follow-up of post-intensive care syndrome

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Institut d'Investigació i Innovació Parc Taulí

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Group
Experimental: ICURA follow-up	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	12-Item Short Form Survey (SF-12) Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	1, 6, 12 months after ICU discharge
Functionality	WHO Short Disability Assessement Schedule (WHODAS 2.0) Scores range from 0 to 60, with higher scores indicating higher level of disability.	1, 6, 12 months after ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptoms	Generalized Anxiety Disorder-7 (GAD-7) Scores range from 0 to 21, with higher scores indicating higher level of symptoms.	1,6,12 months after ICU discharge
Depressive symptoms	Patient Health Questionnaire-9 (PHQ-9) Scores range from 0 to 27, with higher scores indicating higher level of symptoms.	1, 6, 12 months after ICU discharge
Post-Traumatic Stress symptoms	Treatment-Outcome Post-Traumatic Stress Disorder Scale (TOP-8) Scores range from 0 to 32, with higher scores indicating higher level of symptoms.	1, 6, 12 months after ICU discharge
Cognitive status	Montreal Cognitive Assessment (MoCA) Scores range from 0 to 30, with lower scores indicating higher level of cognitive impairment.	1, 6, 12 months after ICU discharge

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Hospital Son Espases; Fundació La Marató de TV3; Universitat de les Illes Balears

Publications and helpful links

General Publications

• Llabres-Alvarez E, Riera-Sagrera M, Llompart-Casasnovas A, Salva P, Castro A, Godoy-Gonzalez M, Dona-Lopez E, Lopez-Aguilar J, Jodar M, Navarra-Ventura G, Gili M, Roca M, Fernandez-Gonzalo S. Implementation of a digital tool for monitoring and managing the emotional and cognitive sequelae of post-intensive care syndrome: ICURA study protocol for a randomised clinical trial. BMJ Open. 2026 Apr 17;16(4):e112976. doi: 10.1136/bmjopen-2025-112976.

Helpful Links

• ICURA project website

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cognition; ICU survivors; Emotional state; Post-intensive Care Syndrome; ICU families
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; postintensive care syndrome
• Other Study ID Numbers: 2022/3031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No