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

NCT ID: NCT06504979

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-02
• Study Completion Date: 2026-08-31

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.

Conditions

Post Intensive Care Syndrome; ICU Survivors; ICU Families

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ICURA follow-up

Group Type: EXPERIMENTAL

Telehealth follow-up of post-intensive care syndrome

Intervention Type: OTHER

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

Standard Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat de les Illes Balears

OTHER

Sponsor Role: collaborator

Hospital Son Espases

OTHER

Sponsor Role: collaborator

Fundació La Marató de TV3

OTHER

Sponsor Role: collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Sol Fernandez-Gonzalo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institut d'Investigació i Innovació Parc Taulí

Sabadell, Barcelona, Spain

Countries

Spain

Related Links

https://www.tauli.cat/es/institut/projectes-i-xarxes/projectes-financats/icura/

ICURA project website

Other Identifiers

2022/3031

Identifier Type: -

Identifier Source: org_study_id