Prevalence and Long Term Effects of Frailty in Elderly In... | NCT06012942

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

NCT06012942

Sponsor

University Hospital of North Norway

Status

Unknown status

Last Update Posted

Aug 28, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Frailty
Critical Illness

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 22, 2023

First Submission Date that Met QC Criteria

Aug 21, 2023

First Posted Date

Aug 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2023

Last Update Posted Date

Aug 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital of North NorwayOTHER

Collaborators

Name	Class
The Royal Norwegian Ministry of Health	OTHER
Haukeland University Hospital	OTHER
University Hospital, Akershus	OTHER
Trondheim University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
ICU readmission	ICU readmission rate	Long-term follow up (1 yr)
ICU-LOS	ICU length of stay	Through total ICU stay, up to 3 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

ICU patients above 65 years old requiring invasive mechanical ventilation> 24 hours are screened for inclusion during the intensive care stay.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bjørn A Kroken, MD	Contact	77669863	+47	bjorn.anders.kroken@unn.no
Shirin K Frisvold, MD/PhD	Contact	77669605	+47	shirin.kordasti@unn.no

Overall Officials

Name	Affiliation	Role
Shirin K Frisvold, MD/PhD	University Hospital of North Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akershus University hospital, General Intensive care department	Recruiting	Lørenskog	Nordbyhagen	1478	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28936626	Background	Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
32868042

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D020969	Disease Attributes

ID	Term
D000073496	Frailty
D016638	Critical Illness