Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504979
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-18
Brief Title:
The Post Intensive Care Syndrome Follow-up and Management Study The ICU Recovery Answers Project
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICURA
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None