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Trial registered on ANZCTR


Registration number
ACTRN12609000973213
Ethics application status
Approved
Date submitted
10/11/2009
Date registered
11/11/2009
Date last updated
13/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Do additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes?
Scientific title
Does providing additional allied health services for inpatients receiving rehabilitation result in a reduced lenth of stay without compromising patient outcomes compared with inpatients receiving standard rehabilitation services?
Secondary ID [1] 262728 0
ID2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health conditions will include conditions of patients admitted for rehabilitation. From our pilot data we expect the most common health conditions to be stroke and hip fracture. 252161 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252363 252363 0 0
Physiotherapy
Physical Medicine / Rehabilitation 252364 252364 0 0
Occupational therapy
Stroke 252365 252365 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group will receive standard rehabilitation from Monday to Friday, plus an additional one hour of physiotherapy and one hour of occupational therapy on Saturday, until discharge from hospital.
Intervention code [1] 241530 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday, until discharge from hospital.
Control group
Active

Outcomes
Primary outcome [1] 253234 0
Patient length of stay defined as the number of overnight stays in the rehabilitation unit from the day of admission until the day of discharge from the unit.
Timepoint [1] 253234 0
At discharge
Primary outcome [2] 253235 0
Quality of life assessed with the EuroQol questionnaire
Timepoint [2] 253235 0
Admission, Discharge, 6 months post discharge, 12 months post discharge
Primary outcome [3] 253236 0
Functional status will be assessed with the Functional Independence Measure (FIM)
Timepoint [3] 253236 0
Admission, Discharge, 6 months post discharge, 12 months post discharge
Primary outcome [4] 253237 0
Health service utilisation and costs will be assessed with a health service utilisation questionnaire, and accessing cost data from the rehabilitation facility and Medicare Australia
Timepoint [4] 253237 0
Admission, Discharge, 6 months post discharge, 12 months post discharge
Primary outcome [5] 269326 0
Activity levels will be assessed with the ActivPAL (uniaxial accelerometer based activity monitor) for steps, energy expenditure and time upright on a subgroup of rehabilitation patients admitted with a lower limb orthopaedic diagnosis
Timepoint [5] 269326 0
Prior to discharge from rehabilitation
Secondary outcome [1] 262194 0
Walking speed will be assessed with the 10 metre walk test
Timepoint [1] 262194 0
Admission, Discharge
Secondary outcome [2] 262195 0
Mobility will be assessed with the timed up and go test
Timepoint [2] 262195 0
Admission, Discharge
Secondary outcome [3] 262198 0
Personal Care Participation Assessment and Resource Tool (PC-PART)
Timepoint [3] 262198 0
Admission, discharge
Secondary outcome [4] 262199 0
Movement, arm function, hand function, walking, and sitting balance in patients with a neurological diagnosis will be assessed with The Modified Motor Assessment scale
Timepoint [4] 262199 0
Admission, discharge
Secondary outcome [5] 262200 0
Discharge destination, either home, low level residential care, high level residential care, acute hospital transfer
Timepoint [5] 262200 0
Discharge

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Have been admitted for rehabilitation at The Angliss Hospital or Peter James Centre
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. If admitted for geriatric evaluation and management
2. If they or their next of kin do not give informed consent to participate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation stratified for site and casemix (neurological and other) generated by computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
1/07/2010
Date of last participant enrolment
Anticipated
30/12/2011
Actual
30/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
712
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2209 0
3128
Recruitment postcode(s) [2] 2210 0
3156
Recruitment postcode(s) [3] 2211 0
3131

Funding & Sponsors
Funding source category [1] 244000 0
Government body
Name [1] 244000 0
National Health and Medical Research Council
Country [1] 244000 0
Australia
Primary sponsor type
Individual
Name
Nicholas Taylor
Address
School of Physiotherapy
La Trobe University
Bundoora
Victoria
3086
Country
Australia
Secondary sponsor category [1] 251352 0
Individual
Name [1] 251352 0
Natasha Brusco
Address [1] 251352 0
Angliss Hospital
Albert Street
Upper Ferntree Gully
Victoria
3156
Country [1] 251352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244105 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 244105 0
Ethics committee country [1] 244105 0
Australia
Date submitted for ethics approval [1] 244105 0
01/12/2009
Approval date [1] 244105 0
16/06/2010
Ethics approval number [1] 244105 0
FHEC 10/14
Ethics committee name [2] 244106 0
Eastern Health Research and Ethics
Ethics committee address [2] 244106 0
Ethics committee country [2] 244106 0
Australia
Date submitted for ethics approval [2] 244106 0
23/11/2009
Approval date [2] 244106 0
08/06/2010
Ethics approval number [2] 244106 0
E58/0910

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30490 0
Prof Nicholas Taylor
Address 30490 0
Department of Physiotherapy
La Trobe University
Bundoora
Victoria 3086
Country 30490 0
Australia
Phone 30490 0
61 3 9479 5860
Fax 30490 0
Email 30490 0
[email protected]
Contact person for public queries
Name 13737 0
Nicholas Taylor
Address 13737 0
School of Physiotherapy
La Trobe University
Bundoora
Victoria
3086
Country 13737 0
Australia
Phone 13737 0
61 3 94795860
Fax 13737 0
Email 13737 0
[email protected]
Contact person for scientific queries
Name 4665 0
Nicholas Taylor
Address 4665 0
School of Physiotherapy
La Trobe University
Bundoora
Victoria
3086
Country 4665 0
Australia
Phone 4665 0
61 3 94795860
Fax 4665 0
Email 4665 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
EmbaseEvaluation of the internal construct validity of the Personal Care Participation Assessment and Resource Tool (PC-PART) using Rasch analysis.2014https://dx.doi.org/10.1186/s12913-014-0543-z
EmbaseIs cost effectiveness sustained after weekend inpatient rehabilitation? 12 month follow up from a randomized controlled trial.2015https://dx.doi.org/10.1186/s12913-015-0822-3
EmbaseResponsiveness, construct and criterion validity of the Personal Care-Participation Assessment and Resource Tool (PC-PART).2015https://dx.doi.org/10.1186/s12955-015-0322-5
Dimensions AIEmpirical evidence of recall bias for primary health care visits2015https://doi.org/10.1186/s12913-015-1039-1
N.B. These documents automatically identified may not have been verified by the study sponsor.