NCT06504979

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

June 18, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 2, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

June 18, 2024

Last Update Submit

March 10, 2026

Conditions

ICU SurvivorsICU FamiliesPost Intensive Care Syndrome

Keywords

Post-intensive Care SyndromeICU survivorsICU familiesCognitionEmotional state

Outcome Measures

Primary Outcomes (2)

  • Health-related quality of life

    12-Item Short Form Survey (SF-12) Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

    1, 6, 12 months after ICU discharge

  • Functionality

    WHO Short Disability Assessement Schedule (WHODAS 2.0) Scores range from 0 to 60, with higher scores indicating higher level of disability.

    1, 6, 12 months after ICU discharge

Secondary Outcomes (4)

  • Anxiety symptoms

    1,6,12 months after ICU discharge

  • Depressive symptoms

    1, 6, 12 months after ICU discharge

  • Post-Traumatic Stress symptoms

    1, 6, 12 months after ICU discharge

  • Cognitive status

    1, 6, 12 months after ICU discharge

Study Arms (2)

ICURA follow-up

EXPERIMENTAL
Other: Telehealth follow-up of post-intensive care syndrome

Standard Group

NO INTERVENTION

Interventions

Telehealth follow-up of post-intensive care syndromeOTHER

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

ICURA follow-up

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥18 years old) critically ill patients admitted to the ICU with or without need of invasive mechanical ventilation (IMV).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut d'Investigació i Innovació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Links

MeSH Terms

Conditions

postintensive care syndrome

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 18, 2024

First Posted

July 17, 2024

Study Start

October 2, 2024

Primary Completion

March 31, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

ES(1)