ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12614001008617

Ethics application status

Approved

Date submitted

10/09/2014

Date registered

18/09/2014

Date last updated

8/12/2024

Date data sharing statement initially provided

8/12/2024

Date results provided

8/12/2024

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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

Inter-rater reliability of Acute Care Index of Function

Timepoint [1]

Any time point beyond Day 3 of ICU admission until ICU discharge.

Secondary outcome [1]

Validity of Acute Care Index of Function (ACIF) with reference to ICU Mobility Scale (IMS)

Timepoint [1]

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?

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

Completed

Date of first participant enrolment

Anticipated

26/09/2014

Actual

26/09/2014

Date of last participant enrolment

Anticipated

24/12/2014

Actual

24/12/2014

Date of last data collection

Anticipated

Actual

24/12/2014

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment hospital [1]

The Canberra Hospital - Garran

Recruitment postcode(s) [1]

2605 - Garran

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

University

Name [1]

University of Queensland
School of Medicine

Address [1]

St Lucia
Brisbane QLD 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee

Ethics committee address [1]

Canberra Hospital
Yamba Drive
Garran ACT 2605

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/09/2014

Ethics approval number [1]

ETHLR.14.213

Ethics committee name [2]

University of Queensland Medical Research Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

12/09/2014

Ethics approval number [2]

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

Mrs Bernie Bissett

Address

Physiotherapy Department
Building 3 Level 1
Canberra Hospital
Yamba Drive
Garran ACT 2605

Country

Australia

Phone

+61 2 6244 2154

Fax

Bernie.Bissett@act.gov.au

Contact person for public queries

Name

Bernie Bissett

Address

Physiotherapy Department
Building 3 Level 1
Yamba Drive
Canberra Hospital
Garran ACT 2605

Country

Australia

Phone

+61 2 6244 2154

Fax

Bernie.Bissett@act.gov.au

Contact person for scientific queries

Name

Bernie Bissett

Address

Physiotherapy Department
Building 3 Level 1
Canberra Hospital
Yamba Drive
Garran ACT 2605

Country

Australia

Phone

+61 2 6244 2154

Fax

Bernie.Bissett@act.gov.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

Historically consent did not include this (note study was 2014)

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	Reliability and utility of the Acute Care Index of Function in intensive care patients: An observational study.	2016	https://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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically