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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06012942
Acronym
SkrInt
Enrollment
300
Registered
2023-08-28
Start date
2022-07-07
Completion date
2025-12-31
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Frailty

Keywords

clinical frailty scale, mechanical ventilation, elderly, EQ-5D-5L

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.

Interventions

None listed

Sponsors

The Royal Norwegian Ministry of Health
CollaboratorOTHER
Haukeland University Hospital
CollaboratorOTHER
University Hospital, Akershus
CollaboratorOTHER
Trondheim University Hospital
CollaboratorOTHER
Bodø Hospital
CollaboratorUNKNOWN
University Hospital of North Norway
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Clinical frailty scoreChange in Clinical Frailty score from 3 months to 12 months follow upScore from 1 to 9.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)Change in EQ-5D-5L from 3 months to 12 monthsThe scale measures quality of life on a 5-component scale
MortalityICU-stay or subsequent 12 months.Mortality during ICU-stay or subsequent 12 months.

Secondary

MeasureTime frameDescription
ICU readmissionLong-term follow up (1 yr)ICU readmission rate
ICU-LOSThrough total ICU stay, up to 3 monthsICU length of stay
Treatment intensity levelFrom inclusion in the study to discharge from intensive care unit, up to three months.ICU treatment intensity level

Countries

Norway

Contacts

Primary ContactBjørn A Kroken, MD
bjorn.anders.kroken@unn.no77669863
Backup ContactShirin K Frisvold, MD/PhD
shirin.kordasti@unn.no77669605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026