CClinicalTrials.gg
Active, not recruitingNCT06504979ICURAUpdated May 27, 2026

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

An interventional study of Telehealth follow-up of post-intensive care syndrome in Post Intensive Care Syndrome, ICU Survivors and ICU Families, sponsored by Corporacion Parc Tauli. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

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.

02

Conditions studied

  • Post Intensive Care Syndrome
  • ICU Survivors
  • ICU Families

Keywords

  • Post-intensive Care Syndrome
  • ICU survivors
  • ICU families
  • Cognition
  • Emotional state
03

In context

postintensive care syndrome

45 studies on the registry are indexed under postintensive care syndrome; 27 are open to participants now.

This study's planned enrollment of 360 is above the median of 90 across 23 interventional studies indexed under postintensive care syndrome.

Browse postintensive care syndrome studies →

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    ICURA follow-up

    Other: Telehealth follow-up of post-intensive care syndrome

  • No intervention
    Standard Group

Interventions

  • OtherTelehealth 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1, 6, 12 months after ICU discharge

  2. Functionality

    WHO Short Disability Assessement Schedule (WHODAS 2.0) Scores range from 0 to 60, with higher scores indicating higher level of disability.

    Time frame: 1, 6, 12 months after ICU discharge

Secondary outcomes

  1. Anxiety symptoms

    Generalized Anxiety Disorder-7 (GAD-7) Scores range from 0 to 21, with higher scores indicating higher level of symptoms.

    Time frame: 1,6,12 months after ICU discharge

  2. Depressive symptoms

    Patient Health Questionnaire-9 (PHQ-9) Scores range from 0 to 27, with higher scores indicating higher level of symptoms.

    Time frame: 1, 6, 12 months after ICU discharge

  3. 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.

    Time frame: 1, 6, 12 months after ICU discharge

  4. Cognitive status

    Montreal Cognitive Assessment (MoCA) Scores range from 0 to 30, with lower scores indicating higher level of cognitive impairment.

    Time frame: 1, 6, 12 months after ICU discharge

07

Study locations

1 site
  • Institut d'Investigació i Innovació Parc Taulí
    Sabadell, Barcelona 08208, Spain
08

References and documents

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. PubMed 41997709 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06504979
Lead sponsor
Corporacion Parc Tauli
Collaborators
Universitat de les Illes Balears, Hospital Son Espases, Fundació La Marató de TV3
Responsible party
Sol Fernandez-Gonzalo (Principal Investigator, Corporacion Parc Tauli) — Principal investigator
First posted
Jul 17, 2024
Start date
Oct 2, 2024
Primary completion
Jan 15, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
May 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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