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NCT Number: NCT06504979

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

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.

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Key information

Conditions

Post Intensive Care Syndrome ICU Families ICU Survivors postintensive care syndrome

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut d'Investigació i Innovació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telehealth follow-up of post-intensive care syndrome

Other

Using a telehealth platform for the detection of the emotional, neuropsychological and physical PICS-related sequelae along 12 months in ICU survivors

Primary outcomes

  1. Health-related quality of life

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

    12-Item Short Form Survey (SF-12) Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

  2. Functionality

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

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

Secondary outcomes

  1. Anxiety symptoms

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

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

  2. Depressive symptoms

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

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

  3. Post-Traumatic Stress symptoms

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

    Treatment-Outcome Post-Traumatic Stress Disorder Scale (TOP-8) Scores range from 0 to 32, with higher scores indicating higher level of symptoms.

  4. Cognitive status

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

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

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Fundació La Marató de TV3
  • Hospital Son Espases
  • Universitat de les Illes Balears

Registry information

Official study title

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

Acronym: ICURA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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