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

Recruiting

• Conditions: Critical Illness; Frailty

• Registration Number: NCT06012942
• Lead Sponsor: University Hospital of North Norway

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.

Study Timeline

• Study Start: 2022-07-07
• Status Verified: 2023-02
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EuroQol 5-Dimension 5-Level (EQ-5D-5L)	Change in EQ-5D-5L from 3 months to 12 months	The scale measures quality of life on a 5-component scale
Mortality	ICU-stay or subsequent 12 months.	Mortality during ICU-stay or subsequent 12 months.
Change in Clinical frailty score	Change in Clinical Frailty score from 3 months to 12 months follow up	Score from 1 to 9.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Haukeland University hospital, General Intensive care unit; 🇳🇴 Bergen, Norway

Akershus University hospital, General Intensive care department; 🇳🇴 Lørenskog, Nordbyhagen, Norway

Nordlandssykehuset Bodø, Intensivavdelingen; 🇳🇴 Bodø, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

Trondheim University hospital, General Intensive care department; 🇳🇴 Trondheim, Norway