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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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] 285809 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
293708 0
293709 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294007 294007 0 0
Other physical medicine / rehabilitation

Study type
Patient registry
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] 290782 0
Not applicable
Comparator / control treatment
Not applicable
Control group

Primary outcome [1] 293787 0
Timepoint [1] 293787 0
12 months after enrolment
Secondary outcome [1] 311838 0
ICU mobility scale (IMS)
Timepoint [1] 311838 0
On awakening in ICU and at discharge from ICU
Secondary outcome [2] 311839 0
Medical Research Council Manual Muscle Test Sum Score (MRC-SS)
Timepoint [2] 311839 0
On awakening in ICU and at discharge from ICU
Secondary outcome [3] 311840 0
Timepoint [3] 311840 0
In ICU, hospital and at 6 months after enrolment
Secondary outcome [4] 311841 0
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] 311841 0
At 6 and 12 months after enrolment
Secondary outcome [5] 311842 0
Return to employment
Timepoint [5] 311842 0
At 6 and 12 months after enrolment
Secondary outcome [6] 311843 0
Short form 12 (quality of life measure)
Timepoint [6] 311843 0
At 6 and 12 months after enrolment
Secondary outcome [7] 311844 0
EQ-5D (quality of life measure)
Timepoint [7] 311844 0
At 6 and 12 months after enrolment
Secondary outcome [8] 311845 0
GOS-E (functional outcome measure)
Timepoint [8] 311845 0
At 6 and 12 months after enrolment

Key inclusion criteria
Patients over 50 years of age.
Admitted to ICU under the trauma unit.
Minimum age
50 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
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
Natural history
Defined population
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 290370 0
Name [1] 290370 0
Alfred Hospital
Address [1] 290370 0
55 Commercial Rd, Melbourne VIC 3004
Country [1] 290370 0
Funding source category [2] 290420 0
Name [2] 290420 0
Monash University
Address [2] 290420 0
Monash University
99 Commercial Rd
Melbourne, VIC
Country [2] 290420 0
Primary sponsor type
Claire Tipping
Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran, Vic 3004
Secondary sponsor category [1] 289092 0
Name [1] 289092 0
Dr Carol Hodgson
Address [1] 289092 0
ANZIC-RC, DEPM, Level 6 Alfred Centre, 99 Commercial Rd, Melbourne, Vic 3004
Country [1] 289092 0
Secondary sponsor category [2] 289093 0
Name [2] 289093 0
Dr Anne Holland
Address [2] 289093 0
La Trobe University / Alfred Health Level 4, The Alfred Centre 99 Commercial Rd,
Melbourne VIC 3004
Country [2] 289093 0
Secondary sponsor category [3] 289094 0
Name [3] 289094 0
Dr Megan Harrold
Address [3] 289094 0
School of Physiotherapy & Exercise Science, Curtin University GPO Box U1987, Perth, WA 6845
Country [3] 289094 0

Ethics approval
Ethics application status
Ethics committee name [1] 292073 0
Alfred Hospital
Ethics committee address [1] 292073 0
Ethics committee country [1] 292073 0
Date submitted for ethics approval [1] 292073 0
Approval date [1] 292073 0
Ethics approval number [1] 292073 0

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

Principal investigator
Name 53358 0
Miss Claire Tipping
Address 53358 0
Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran 3004
Melbourne Vic
Country 53358 0
Phone 53358 0
+ 61 3 9076 3450
Fax 53358 0
Email 53358 0
Contact person for public queries
Name 53359 0
Miss Claire Tipping
Address 53359 0
Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran 3004
Melbourne Vic
Country 53359 0
Phone 53359 0
+61 3 90763450
Fax 53359 0
Email 53359 0
Contact person for scientific queries
Name 53360 0
Dr Carol Hodgson
Address 53360 0
ANZIC-RC, DEPM, Monash University
99 Commercial Rd, Melbourne, Vic, 3004
Country 53360 0
Phone 53360 0
+61 3 9903 0598
Fax 53360 0
Email 53360 0

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?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Other publication details
Citation type [1] 1622 0
Citation/DOI/link/details [1] 1622 0
The impact of frailty in critically ill trauma patients: a prospective observational study, Australasian Trauma Society ASM, 2018.
Attachments [1] 1622 0
Citation type [2] 1649 0
Citation/DOI/link/details [2] 1649 0
Tipping C, Chan T, Harrold M, Holland A, Hodgson C. Using frailty to predict mortality in Australian ICU patients following trauma: A prospective observational study comparing two frailty measures. Aust Crit Care. 2018;31(2):113.
Attachments [2] 1649 0
Citation type [3] 1650 0
Citation/DOI/link/details [3] 1650 0
Comparing two frailty measures in trauma ICU, ANZICS Intensive Care ASM, 2017
Attachments [3] 1650 0
Citation type [4] 1651 0
Citation/DOI/link/details [4] 1651 0
Frailty and function following trauma, AAMVC- ICU Physiotherapy and Multidisciplinary Symposium, 2017
Attachments [4] 1651 0
Citation type [5] 1652 0
Conference poster
Citation/DOI/link/details [5] 1652 0
Poster Presentation at Alfred Hospital Research week, Melbourne, Australia - Frailty in Trauma ICU patients, 2017
Attachments [5] 1652 0
Results – basic reporting
Results – plain English summary