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

Not Applicable

• Conditions: Post Intensive Care Syndrome; ICU Survivors; ICU Families
• Interventions: Other: Telehealth follow-up of post-intensive care syndrome

• Registration Number: NCT06504979
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-17
• Study Start: 2024-10-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-07
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICURA follow-up	Telehealth follow-up of post-intensive care syndrome	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institut d'Investigació i Innovació Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain