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

NCT06504979 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-03-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Universitat de les Illes Balears

    collaborator OTHER

  • Hospital Son Espases

    collaborator OTHER

  • Fundació La Marató de TV3

    collaborator OTHER

  • Corporacion Parc Tauli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504979 on ClinicalTrials.gov