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

Sponsor

University Hospital of North Norway (Other)

Overall Status

Recruiting

CT.gov ID

NCT06012942

Collaborator

The Royal Norwegian Ministry of Health (Other), Haukeland University Hospital (Other), University Hospital, Akershus (Other), Trondheim University Hospital (Other), Bodø Hospital (Other)

300

Enrollment

Locations

41.8

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty Critical Illness

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 7, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

Change in Clinical frailty score [Change in Clinical Frailty score from 3 months to 12 months follow up]
Score from 1 to 9.
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akershus University hospital, General Intensive care department	Lørenskog	Nordbyhagen	Norway	1478
2	Haukeland University hospital, General Intensive care unit	Bergen		Norway	5021
3	Nordlandssykehuset Bodø, Intensivavdelingen	Bodø		Norway	8005
4	University Hospital of North Norway	Tromsø		Norway	9038
5	Trondheim University hospital, General Intensive care department	Trondheim		Norway	7006