Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06012942
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-02-22
Brief Title:
Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SkrInt
Brief Summary:
The primary aim is to study change of critical frailty scale CFS and health related quality of life EQ-5D-5L in a long-term follow-up of ICU survivors We aim to identify important ICU related predictors for change in CFS and EQ-5D-5L in long term follow up 1 yr
Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment intensity level severity score and mortality
Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment intensity level severity score and mortality
Detailed Description:
This is a multi-centre norwegian observational prospective multicenter Norway coordinated from University hospital North Norway Tromso
The study is approved by The Regional Committee for Medical Research Ethics Northern Norway
The following scores will be assessed by asking the patient and relative during ICU stay CFS EQ5DL before current critical illness
The following demographic and clinical data will be retrieved from the medical records Comorbidity before critical illness reasons for ICU admission daily severity score SOFA- score length of mechanical ventilation dialysis tracheostomy Habitat before and after ICU treatment ICU and hospital length of stay complications retrieved during intensive care treatment mortality limitation of treatment
The patients will be followed up with telephone interview after hospital discharge for evaluation of Comorbidity CFS EQ5DData for all sites are collected and managed using RedCap electronic data capture tools
Three research nurses will do the follow up with telephone interviews on all sites and record the data in RedCap
We aim to enroll 300 patients before 31 Des 2024
The study is approved by The Regional Committee for Medical Research Ethics Northern Norway
The following scores will be assessed by asking the patient and relative during ICU stay CFS EQ5DL before current critical illness
The following demographic and clinical data will be retrieved from the medical records Comorbidity before critical illness reasons for ICU admission daily severity score SOFA- score length of mechanical ventilation dialysis tracheostomy Habitat before and after ICU treatment ICU and hospital length of stay complications retrieved during intensive care treatment mortality limitation of treatment
The patients will be followed up with telephone interview after hospital discharge for evaluation of Comorbidity CFS EQ5DData for all sites are collected and managed using RedCap electronic data capture tools
Three research nurses will do the follow up with telephone interviews on all sites and record the data in RedCap
We aim to enroll 300 patients before 31 Des 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None