Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000106235
Ethics application status
Approved
Date submitted
9/01/2009
Date registered
16/02/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the effectiveness of a physiotherapy service to the Emergency Extended Care Unit
Scientific title
Effect of physiotherapy for patients in the Emergency Extended Care Unit on the rate of admission to hospital
Secondary ID [1] 262703 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients in an Emergency Extended Care Unit 4181 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4391 4391 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Group patients will be assessed on a single occasion by a physiotherapist within a few hours of their inclusion into the study. This physiotherapist will provide appropriate treatment based on their assessment findings. This treatment may include education/advice, provision of mobility aids, prescription of exercises and organising appropriate community equipment/resources. This assessment/treatment intervention will last as long as the physiotherapist deems necessary.
Intervention code [1] 3900 0
Treatment: Other
Comparator / control treatment
Control Group patients will receive the usual medical/nursing care provided to Emergency Extended Care Unit (EECU) patients and allowed to go home, or be admitted to hospital if deemed appropriate, with no alteration to the usual discharge/admission plan formulated by medical/nursing staff in EECU.
Control group
Active

Outcomes
Primary outcome [1] 5269 0
Admission rate from EECU to hospital will be recorded from data obtained from the Royal Adelaide Hospital Australian Patient Management System.
Timepoint [1] 5269 0
At admission to hospital or discharge from EECU
Secondary outcome [1] 8881 0
Re-presentation rate to Emergency Department (ED)/EECU will be recorded from data obtained from the RAH Australian Patient Management System
Timepoint [1] 8881 0
30 days after presentation to EECU

Eligibility
Key inclusion criteria
All patients admitted to the RAH EECU who are deemed to require physiotherapy intervention by physiotherapy, medical and/or nursing staff and are able to provide informed, written consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted to EECU over a weekend or public holiday will not be included for practical reasons and in an effort to control costs.
Patients who are unwilling to participate in the study.
Patients who are unable to understand sufficient written or spoken English or co-operate with the assessment and treatment procedures.

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)
After satisfying the selection criteria, potential participants will be approached by the principal investigator regarding participation. The principal investigator will explain the project aims and format to them, provide them with the written information sheet and, after allowing them time to consider whether or not they wish to participate, obtain informed written consent from those patients willing to participate. Once consent has been obtained, patients will be assigned to the treatment or control group by referring to sequential sealed opaque envelopes kept in the Physiotherapy Department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random numbers table will be used to generate group allocations.
Masking / blinding
Open (masking not 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
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
186
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4362 0
Hospital
Name [1] 4362 0
Royal Adelaide Hospital /Institute of Medical and Veterinary Science (RAH/IMVS)Research Committee for a Clinical Research Grant for Allied Health, Pharmacy and Nursing 2009
Country [1] 4362 0
Australia
Primary sponsor type
Individual
Name
Christabel Jesudason
Address
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 3929 0
Individual
Name [1] 3929 0
Matthew McInnes
Address [1] 3929 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 3929 0
Australia
Other collaborator category [1] 526 0
Individual
Name [1] 526 0
Kathy Stiller
Address [1] 526 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 526 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6564 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 6564 0
Ethics committee country [1] 6564 0
Australia
Date submitted for ethics approval [1] 6564 0
Approval date [1] 6564 0
08/01/2009
Ethics approval number [1] 6564 0
RAH Protocol No. 090105

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

Contacts
Principal investigator
Name 35079 0
Address 35079 0
Country 35079 0
Phone 35079 0
Fax 35079 0
Email 35079 0
Contact person for public queries
Name 12426 0
Christabel Jesudason
Address 12426 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 12426 0
Australia
Phone 12426 0
+61 9 8 8222 5334
Fax 12426 0
+61 8 8222 4279
Email 12426 0
[email protected]
Contact person for scientific queries
Name 3354 0
Kathy Stiller
Address 3354 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 3354 0
Australia
Phone 3354 0
+61 8 8222 5334
Fax 3354 0
+61 8 8222 4279
Email 3354 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
No additional documents have been identified.