NCT06504979

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2024-10-02
• Primary completion: 2026-03-31
• Completion: 2026-12-01
• First posted: 2024-07-17
• Last updated: 2026-03-12

Locations

1 site across 1 country: Spain