Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001008617
Ethics application status
Approved
Date submitted
10/09/2014
Date registered
18/09/2014
Date last updated
18/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Reliability and validity of the Acute Care Index of Function tool in critical care patients.
Scientific title
In a homogeneous group of critical care patients in a tertiary intensive care unit, does the Acute Care Index of Function tool, as used by physiotherapists, have adequate inter-rater reliability and validity?
Secondary ID [1] 285318 0
Nil
Universal Trial Number (UTN)
U1111-1161-6019
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Care Patients 293033 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293303 293303 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 who have been in intensive care for 3 or more days will undergo usual daily assessment and treatment by the physiotherapists. Each day from Day 3 onwards (until ICU discharge), the treating physiotherapist will complete the Acute Care Index of Function tool to obtain a numerical score of overall function. Completion of the assessment tool will take less than 5 minutes, presuming the physiotherapist undertook a comprehensive functional assessment as part of the patient's routine care.This ACIF score will be stored electronically.
Intervention code [1] 290230 0
Not applicable
Comparator / control treatment
A second physiotherapist will also complete an Acute Care Index of Function assessment, independently of the first assessor, using a paper-based format.
The ICU Mobility Scale (IMS) will also be recorded daily after Day 3 of admission, to allow validation against an established functional measure.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293142 0
Inter-rater reliability of Acute Care Index of Function
Timepoint [1] 293142 0
Any time point beyond Day 3 of ICU admission until ICU discharge.
Secondary outcome [1] 310439 0
Validity of Acute Care Index of Function (ACIF) with reference to ICU Mobility Scale (IMS)
Timepoint [1] 310439 0
Any time point beyond Day 3 of ICU admission until ICU discharge.

Eligibility
Key inclusion criteria
All patients admitted to Intensive Care Unit are eligible for inclusion (deliberately seeking a heterogeneous convenience sample)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Correlation coefficients (Pearsons) will be calculated between ACIF scores of 2 independent physiotherapy assessors.
Correlation coefficients (Pearsons) will also be calculated between ACIF and IMS scores.
Sub group analysis may be performed based on experience of the assessors involved.
Based on previous reliability studies of ACIF in neurological patients, and the recent reliability study of the IMS (Hodgson et al 2014), we calculated that a sample size of 100 patient assessments would be sufficient to demonstrate adequate inter-rater reliability and validity with reference to the IMS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/09/2014
Actual
Date of last participant enrolment
Anticipated
24/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 2976 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 8687 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 289941 0
Self funded/Unfunded
Name [1] 289941 0
Country [1] 289941 0
Primary sponsor type
Hospital
Name
Acute Support Physiotherapy Department, Canberra Hospital
Address
Building 3 Level 1
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 288630 0
University
Name [1] 288630 0
University of Queensland
School of Medicine
Address [1] 288630 0
St Lucia
Brisbane QLD 4072
Country [1] 288630 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291655 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 291655 0
Canberra Hospital
Yamba Drive
Garran ACT 2605
Ethics committee country [1] 291655 0
Australia
Date submitted for ethics approval [1] 291655 0
Approval date [1] 291655 0
01/09/2014
Ethics approval number [1] 291655 0
ETHLR.14.213
Ethics committee name [2] 291681 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 291681 0
Ethics committee country [2] 291681 0
Australia
Date submitted for ethics approval [2] 291681 0
Approval date [2] 291681 0
12/09/2014
Ethics approval number [2] 291681 0
2014001220

Summary
Brief summary
This study is designed to test whether the Acute Care Index of Function tool, a measure of global function used by Physiotherapists, has adequate reliability between therapists to be useful as an outcome measure in critically ill patients. This tool has been found to be reliable and valid in acute neurological patients but has not yet been tested in a heterogeneous critically ill population. This study will also test the validity of the ACIF by comparing it to the ICU Mobility Scale (IMS) which has been found to have adequate reliability and validity in critically ill patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51366 0
Mrs Bernie Bissett
Address 51366 0
Physiotherapy Department
Building 3 Level 1
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 51366 0
Australia
Phone 51366 0
+61 2 6244 2154
Fax 51366 0
Email 51366 0
[email protected]
Contact person for public queries
Name 51367 0
Mrs Bernie Bissett
Address 51367 0
Physiotherapy Department
Building 3 Level 1
Yamba Drive
Canberra Hospital
Garran ACT 2605
Country 51367 0
Australia
Phone 51367 0
+61 2 6244 2154
Fax 51367 0
Email 51367 0
[email protected]
Contact person for scientific queries
Name 51368 0
Mrs Bernie Bissett
Address 51368 0
Physiotherapy Department
Building 3 Level 1
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 51368 0
Australia
Phone 51368 0
+61 2 6244 2154
Fax 51368 0
Email 51368 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseReliability and utility of the Acute Care Index of Function in intensive care patients: An observational study.2016https://dx.doi.org/10.1016/j.hrtlng.2015.09.008
N.B. These documents automatically identified may not have been verified by the study sponsor.