ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000039583

Ethics application status

Approved

Date submitted

22/12/2014

Date registered

19/01/2015

Date last updated

18/03/2019

Date data sharing statement initially provided

18/03/2019

Date results provided

18/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Frailty in intensive care (ICU) trauma patients: a prospective observational study.

Scientific title

An observational study of trauma ICU patients comparing frailty with age and co-morbidities in regards to mortality and morbidity.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Frailty

Trauma

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is an observational study and therefore there are no interventions. Patients will be observed during their ICU stay and at 2 follow up time points (6 and 12 months post enrolment). The key outcomes are long term mortality and morbidity.

Intervention code [1]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Mortality

Timepoint [1]

12 months after enrolment

Secondary outcome [1]

ICU mobility scale (IMS)

Timepoint [1]

On awakening in ICU and at discharge from ICU

Secondary outcome [2]

Medical Research Council Manual Muscle Test Sum Score (MRC-SS)

Timepoint [2]

On awakening in ICU and at discharge from ICU

Secondary outcome [3]

Mortality

Timepoint [3]

In ICU, hospital and at 6 months after enrolment

Secondary outcome [4]

Living situation (lives with family/friend, lives alone or other [nursing home, hospice etc]. This will be determined from questioning the participant or their person responsible.

Timepoint [4]

At 6 and 12 months after enrolment

Secondary outcome [5]

Return to employment

Timepoint [5]

At 6 and 12 months after enrolment

Secondary outcome [6]

Short form 12 (quality of life measure)

Timepoint [6]

At 6 and 12 months after enrolment

Secondary outcome [7]

EQ-5D (quality of life measure)

Timepoint [7]

At 6 and 12 months after enrolment

Secondary outcome [8]

GOS-E (functional outcome measure)

Timepoint [8]

At 6 and 12 months after enrolment

Eligibility

Key inclusion criteria

Patients over 50 years of age.
Admitted to ICU under the trauma unit.

Minimum age

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Unable to communicate in English
Expected ICU length of stay <24 hours
Re-admission to ICU
ICU admission for palliation
Death is deemed imminent and inevitable
Unable to gain informed consent

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Statistical analysis will be completed using SAS version 9.3 (SAS Institute Inc., Cary, NC, USA). All available data will be analysed. Data will be assessed for normality and descriptive statistics will be presented as mean and standard deviations for normally distributed data and medians and interquartile range for non-normally distributed data. Continuous data will be compared using Student’s t-tests for normally distributed data and Wilcoxon rank-sum tests for non-normally distributed variables. Categorical data will be expressed as frequencies and percentages and will be compared using chi-square tests.

Patients will be dichotomised into two independent groups; frail and non-frail (frail, FP greater than or equals to 3 or CFS greater than 4 and non-frail, FP less than 3 or CFS less than or equals to 4). Survival for frail and non-frail patients will be analysed between groups using a log-rank test. Multivariable regression will be performed to identify the independent factors associated with ICU and six and 12 month mortality. Adjusted odds ratios (OR) and 95% confidence intervals (95% CI) of the OR will be calculated.

A two sided p-value of 0.05 will be considered statistically significant

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

20/04/2015

Actual

20/04/2015

Date of last participant enrolment

Anticipated

Actual

11/04/2017

Date of last data collection

Anticipated

11/04/2018

Actual

11/04/2018

Sample size

Target

200

Accrual to date

Final

138

Recruitment in Australia

Recruitment state(s)

WA,VIC

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alfred Hospital

Address [1]

55 Commercial Rd, Melbourne VIC 3004

Country [1]

Australia

Funding source category [2]

University

Name [2]

Monash University

Address [2]

Monash University
99 Commercial Rd
Prahran
Melbourne, VIC
3004

Country [2]

Australia

Primary sponsor type

Individual

Name

Claire Tipping

Address

Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran, Vic 3004
Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Carol Hodgson

Address [1]

ANZIC-RC, DEPM, Level 6 Alfred Centre, 99 Commercial Rd, Melbourne, Vic 3004

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr Anne Holland

Address [2]

La Trobe University / Alfred Health Level 4, The Alfred Centre 99 Commercial Rd,
Melbourne VIC 3004

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Dr Megan Harrold

Address [3]

School of Physiotherapy & Exercise Science, Curtin University GPO Box U1987, Perth, WA 6845

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/11/2014

Approval date [1]

09/01/2015

Ethics approval number [1]

527/14

Summary

Brief summary

The elderly population in Australia is continuing to increase with the number of people over 65 years of age increasing from approximately 2.7 million in 2006 to 3 million in 2011. As people living longer they are exposed to a higher risk of trauma. Studies have shown that the elderly trauma population (over 65 years of age) have significantly higher mortality, increased ventilator days and longer ICU and hospital length of stay (LOS) compared to a younger population. Frailty is a widely used term to classify a multi-factorial syndrome comprising of physical and cognitive changes leading to increased vulnerability. Frailty is associated with increased risk of adverse events which are associated with higher cost of health care and care needs of patients. The prevalence of frailty amongst the critically ill population has been reported as 13% of all patients and 32.8% in patients over 50 years of age. Frail patients admitted to the intensive care unit (ICU) have been shown to have higher in-hospital mortality and lower quality of life at 6 month follow up. During the ICU admission, frail patients had more major adverse events and longer ICU and hospital LOS. There is no clear consensus on how to measure frailty, however two methods have been utilised in ICU research, the Phenotype Frailty (PF) and the Clinical frailty score (CFS). Historically elderly trauma patient outcomes have been investigated in relation to age and co-morbidities. This study aims to determine whether frailty is predictive of mortality and functional outcomes, which of two frailty measures is more effective at predicting mortality and functional outcomes and whether frailty is more effective at predicting mortality and functional outcomes compared to other patient measures (i.e. age, co-morbidities or injury severity score). METHODS: Prospective observational study, in 2 Australian ICUs (the Alfred Hospital and Royal Perth Hospital). We aim to recruit 200 patients admitted to ICU under the trauma unit, 50 years of age and over. Primary outcome measures include mortality (in ICU, hospital, 6 months and 12 months) and function using the GOS-E. Secondary outcome measure include (but not limited to) frailty, pre-morbid function, level of treatment in ICU, functional ability at ICU discharge.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss Claire Tipping

Address

Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran 3004
Melbourne Vic

Country

Australia

Phone

+ 61 3 9076 3450

Fax

Email

c.tipping@alfred.org.au

Contact person for public queries

Name

Claire Tipping

Address

Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran 3004
Melbourne Vic

Country

Australia

Phone

+61 3 90763450

Fax

Email

c.tipping@alfred.org.au

Contact person for scientific queries

Name

Carol Hodgson

Address

ANZIC-RC, DEPM, Monash University
99 Commercial Rd, Melbourne, Vic, 3004

Country

Australia

Phone

+61 3 9903 0598

Fax

Email

carol.hodgson@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Frailty in Patients With Trauma Who Are Critically Ill: A Prospective Observational Study to Determine Feasibility, Concordance, and Construct and Predictive Validity of 2 Frailty Measures.	2019	https://dx.doi.org/10.1093/ptj/pzz057

N.B. These documents automatically identified may not have been verified by the study sponsor.