Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients (SkrInt)
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| ClinicalTrials.gov Identifier: NCT06012942 |
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Recruitment Status :
Recruiting
First Posted : August 28, 2023
Last Update Posted : August 28, 2023
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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 |
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| Frailty Critical Illness |
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 Type : | Observational |
| Estimated 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 : | July 7, 2022 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | December 31, 2025 |
- 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.
- 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.
- ICU readmission [ Time Frame: Long-term follow up (1 yr) ]ICU readmission rate
- ICU-LOS [ Time Frame: Through total ICU stay, up to 3 months ]ICU length of stay
- Treatment intensity level [ Time Frame: From inclusion in the study to discharge from intensive care unit, up to three months. ]ICU treatment intensity level
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06012942
| Contact: Bjørn A Kroken, MD | 77669863 ext +47 | bjorn.anders.kroken@unn.no | |
| Contact: Shirin K Frisvold, MD/PhD | 77669605 ext +47 | shirin.kordasti@unn.no |
| Norway | |
| Akershus University hospital, General Intensive care department | Recruiting |
| Lørenskog, Nordbyhagen, Norway, 1478 | |
| Contact: Ole Kristian Fossum, MD/PhD Ole.Kristian.Fossum@ahus.no | |
| Haukeland University hospital, General Intensive care unit | Recruiting |
| Bergen, Norway, 5021 | |
| Contact: Reidar Kvåle, MD7PhD reidar.kvale@helse-bergen.no | |
| Nordlandssykehuset Bodø, Intensivavdelingen | Recruiting |
| Bodø, Norway, 8005 | |
| Contact: Kristin S Berg, MD/PhD kristin.berg2@nordlandssykehuset.no | |
| University Hospital of North Norway | Recruiting |
| Tromsø, Norway, 9038 | |
| Contact: Bjørn A Kroken, MD 97514485 ext +47 bjorn.anders.kroken@unn.no | |
| Trondheim University hospital, General Intensive care department | Recruiting |
| Trondheim, Norway, 7006 | |
| Contact: Daniel Bergum, MD/PhD Daniel.Bergum@stolav.no | |
| Principal Investigator: | Shirin K Frisvold, MD/PhD | University Hospital of North Norway |
| Responsible Party: | University Hospital of North Norway |
| ClinicalTrials.gov Identifier: | NCT06012942 |
| Other Study ID Numbers: |
HNF1632-22 |
| First Posted: | August 28, 2023 Key Record Dates |
| Last Update Posted: | August 28, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices). |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Beginning 12 months and ending 5 years following article publication. |
| Access Criteria: | The presented dataset will be considered available from the corresponding author on reasonable request based on formal national approvals. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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clinical frailty scale mechanical ventilation elderly EQ-5D-5L |
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Frailty Critical Illness Pathologic Processes Disease Attributes |