Clinical trial NCT06504979: The Post Intensive Care Syndrome Follow-up and Management Study: the ICU Recovery Answers Project
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Post Intensive Care Syndrome
ICU Survivors
ICU Families
Keywords: Post-intensive Care Syndrome
ICU survivors
ICU families
Cognition
Emotional state
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Universitat de les Illes Balears
name: Hospital Son Espases
name: Fundació La Marató de TV3
First posted: 2024-07-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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 outcomes:
measure: Health-related quality of life
timeFrame: 1 year
measure: Functionality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Institut d'Investigació i Innovació Parc Taulí
state: Barcelona
Study officials:
References: