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Clinical Trials/NCT06012942
NCT06012942
Recruiting
Not Applicable

Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients

University Hospital of North Norway5 sites in 1 country300 target enrollmentJuly 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
University Hospital of North Norway
Enrollment
300
Locations
5
Primary Endpoint
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 7, 2022
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital of North Norway
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • \>= 65 years
  • ≥ 24 hours mechanical ventilation
  • Written informed consent from patient or next of kin

Exclusion Criteria

  • Readmission of patient included in the study
  • Not possible to obtain a valid CFS or and EQ-5D-5L at admission or follow-up of CFS because of social context or language.

Outcomes

Primary Outcomes

EuroQol 5-Dimension 5-Level (EQ-5D-5L)

Time Frame: Change in EQ-5D-5L from 3 months to 12 months

The scale measures quality of life on a 5-component scale

Mortality

Time Frame: ICU-stay or subsequent 12 months.

Mortality during ICU-stay or subsequent 12 months.

Change in Clinical frailty score

Time Frame: Change in Clinical Frailty score from 3 months to 12 months follow up

Score from 1 to 9.

Secondary Outcomes

  • ICU readmission(Long-term follow up (1 yr))
  • ICU-LOS(Through total ICU stay, up to 3 months)
  • Treatment intensity level(From inclusion in the study to discharge from intensive care unit, up to three months.)

Study Sites (5)

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