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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000536369
Ethics application status
Approved
Date submitted
10/04/2017
Date registered
12/04/2017
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Date results information initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The minimal important difference of the ICU mobility scale.
Scientific title
Calculating the minimal important difference of the ICU mobility scale in adult ICU patients.
Secondary ID [1] 291366 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 302350 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301936 301936 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will be observed through an intensive care or high dependency care unit stay, from admission to discharge. There will be no change to standard care and the patients will not be required to complete any additional tests for the study.
Intervention code [1] 297391 0
Not applicable
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301359 0
ICU mobility scale
Timepoint [1] 301359 0
ICU admission and ICU discharge
Secondary outcome [1] 332420 0
The Global rating of change
Timepoint [1] 332420 0
From ICU admission to ICU discharge

Eligibility
Key inclusion criteria
Inclusion criteria: Patients will be screened by a clinical researcher at each site. Patients will be eligible for inclusion if they are:
1) over 18 years of age,
2) admitted to ICU/HDU for over 24 hours and expected to stay for another 24 hours,
3) alive on discharge from ICU,
4) assessed by the same physiotherapist within 24 hours of admission and discharge from ICU and there is at least 48 hours between the two assessments.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Patients will be excluded if the ICU admission or the goals of treatment are for comfort measures only.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The median change in IMS associated with substantial, small and no change on the global rating of change will be compared using a Kruskal-Wallis test.
Distribution based methods used to calculated the MID will be the SEM and the effect size. The SEM is defined as s"1"v(1-r) , where s1 is the standard deviation at baseline (admission to ICU) and r is the test-retest reliability obtained from a previous study. One SEM closely approximates the MID. The effect size quantifies the amount of difference between two means on a unit less scale. A moderate effect size is considered clinically important and is calculated as 0.5 X standard deviation of the change scores from ICU admission to ICU discharge.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7603 0
The Alfred - Prahran
Recruitment hospital [2] 7604 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [3] 7605 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 15502 0
3004 - Prahran
Recruitment postcode(s) [2] 15503 0
3350 - Ballarat Central
Recruitment postcode(s) [3] 15504 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 295838 0
Hospital
Name [1] 295838 0
Alfred Hospital
Address [1] 295838 0
55 Commercial Rd, Melbourne VIC 3004
Country [1] 295838 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 294688 0
University
Name [1] 294688 0
Monash University
Address [1] 294688 0
553 St Kilda Rd
Melbourne VIC 3004
Country [1] 294688 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297120 0
Alfred Hospital
Ethics committee address [1] 297120 0
Office of Ethics and Research Governance
Level One, Old Baker Building
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Ethics committee country [1] 297120 0
Australia
Date submitted for ethics approval [1] 297120 0
19/04/2017
Approval date [1] 297120 0
22/05/2017
Ethics approval number [1] 297120 0

Summary
Brief summary
A prospective multi-center study of adult patients admitted to intensive care (ICU) or high dependency unit's across Victoria. Ethical approval will be sort through The Alfred Hospital, Monash University and the individual ethics boards for each participating site.
This study aims to use anchor and distribution based methods to establish the minimal important difference (MID) of the ICU mobility scale (IMS) in a critically ill population.
Anchor based: Where patients are treated by the same clinician physiotherapist within 24 hours of admission and discharge to ICU they will be asked two questions on the final assessment. “Has the patient’s mobility changed since admission to ICU?” and “If yes, how much have they changed?’
The rate of change will be scored as: 1- almost the same, hardly better at all, 2- a little better, 3- somewhat better, 4- moderately better, 5- a good deal better, 6- a great deal better and 7- a very great deal better. Similar assessments will be made for deterioration, substituting “worse” for “better”11. The IMS will also be independently collected at both time points by a clinical researcher.
Distribution based: The patients’ IMS scores from ICU admission and discharge will be used to estimate the MID using two distribution based methods, the standard error of the mean and the effect size.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73042 0
Ms Claire Tipping
Address 73042 0
Physiotherapy Department, Alfred Hospital
55 Commercial Rd, Melbourne VIC 3004
Country 73042 0
Australia
Phone 73042 0
+61 3 90763450
Fax 73042 0
Email 73042 0
c.tipping@alfred.org.au
Contact person for public queries
Name 73043 0
Ms Claire Tipping
Address 73043 0
Physiotherapy Department, Alfred Hospital
55 Commercial Rd, Melbourne VIC 3004
Country 73043 0
Australia
Phone 73043 0
+ 61 3 9076 3450
Fax 73043 0
Email 73043 0
c.tipping@alfred.org.au
Contact person for scientific queries
Name 73044 0
A/Prof Carol Hodgson
Address 73044 0
ANZIC research centre
Monash University 553 St Kilda Rd
Melbourne, Vic 3004
Country 73044 0
Australia
Phone 73044 0
+61 3 9903 0598
Fax 73044 0
Email 73044 0
carol.hodgson@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was no a condition of our ethics approval
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1619 0
Tipping CJ, Holland AE, Harrold M, Crawford T, Halliburton N, Hodgson CL. The minimal important difference of the ICU mobility scale. Heart Lung. 2018;47(5):497-501.
Attachments [1] 1619 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary