Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000837224
Ethics application status
Not yet submitted
Date submitted
25/07/2009
Date registered
25/09/2009
Date last updated
25/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A 7 day per week physiotherapy service for inpatient rehabilitation patients at Broadmeadows Health Service (BHS), Northern Health: a feasibility study
Scientific title
The effect of weekend physiotherapy in addition to usual care on hospital length of stay and mobility in inpatient rehabilitation patients: a feasibility study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inpatient rehabilitation population 237360 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239681 239681 0 0
Physiotherapy
Public Health 239999 239999 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weekend physiotherapy (either group or 1:1) in addition to usual weekday physiotherapy care. Group session will be conducted for 45mins-1hr Sat adn Sunday. One-to-one therapy will be provided for participants for whom group therapy is not appropriate. One-one therapy will be for up to 30mins (Sat adn Sun) and will depend on the individual needs of the patient. Weekend therapy will be provided for 10 weeks (the duration of the trial)
Intervention code [1] 237016 0
Rehabilitation
Comparator / control treatment
Usual weekday physiotherapy care is usually provided daily Monday to Friday and duration and type of intervention depnding on the client condition and physiotherapy goals. Usual physiotherapy care will remain unchanged for the 10 week duration of this trial.
Control group
Active

Outcomes
Primary outcome [1] 240453 0
problems and obstacles that are identified by staff involved in the project during the trial period (via survey)
Timepoint [1] 240453 0
halfway (5weeks) and at completion (10weeks)
Primary outcome [2] 240454 0
hospital length of stay at BHS
Timepoint [2] 240454 0
at hospital discharge
Primary outcome [3] 240455 0
de Morton Mobility Index (DEMMI) scores (measuring mobility)
Timepoint [3] 240455 0
hospital discharge assessment
Secondary outcome [1] 244984 0
Functional Independence Measure (FIM) and Barthel Index scores. Both measure indepndence in Activities of Daily Living.
Timepoint [1] 244984 0
hospital discharge
Secondary outcome [2] 244985 0
National benchmarking statistics- Australian Rehabilitation Outcomes Centre (AROC)
Timepoint [2] 244985 0
hospital discharge
Secondary outcome [3] 244988 0
discharge destination (will be collected from the patient history in the following categories: home alone, home with other, hostel, nursing home, transitional care program, flexi bed, other)
Timepoint [3] 244988 0
hospital discharge

Eligibility
Key inclusion criteria
Admitted to inpatient rehabilitation ward at BHS, written and informed consent obtained prior to first weekend of inpatient stay,
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
medically unstable (assessed by a member of the medical team), not considered appropriate for weekend physiotherapy by usual care therapist, do not have physiotherapy goals, admitted after 1 pm on Friday, consent not obtained prior to first weekend as an inpatient.

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)
A nursing staff member will invite all persons admitted to the rehab ward during the trials period to participate in the study. An interpreter will be arranged for Non English Speaking Background (NESB) patients. Once written and informed consent is obtained a person who is not involved in the study (who does not have any participant details) will select a sealed opaque envelope that allocates the person to the control or intervention arm of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be generated by computer
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
Not yet recruiting
Date of first participant enrolment
Anticipated
21/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237399 0
Hospital
Name [1] 237399 0
Northern Health
Country [1] 237399 0
Australia
Primary sponsor type
Individual
Name
Ofa Starman
Address
35 Johnstone St
Broadmeadows 3047
Vic
Country
Australia
Secondary sponsor category [1] 236896 0
Hospital
Name [1] 236896 0
Multidisciplinary team on inpatient rehab ward at BHS
Address [1] 236896 0
35 Johnstone St
Broadmeadows 3047
Vic
Country [1] 236896 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239531 0
Ethics committee address [1] 239531 0
Ethics committee country [1] 239531 0
Date submitted for ethics approval [1] 239531 0
27/09/2009
Approval date [1] 239531 0
Ethics approval number [1] 239531 0

Summary
Brief summary
The primary purpose of this study is to identify problems and obstacles to conducting a larger randmoised controlled trial that investigates the effect of weekend physiotherapy (in addition to weekday) compared to weekday only physiotherapy for inpatient rehabilitation patients. It is hypothesised that patients who receive the weekend therapy may achieve their physical goals earlier and have a shorter hospital length of stay.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29966 0
Address 29966 0
Country 29966 0
Phone 29966 0
Fax 29966 0
Email 29966 0
Contact person for public queries
Name 13213 0
Ofa Starman
Address 13213 0
Northern Health
35 Johnstone St
Broadmeadows 3047
Vic
Country 13213 0
Australia
Phone 13213 0
+61 3 8345 5172
Fax 13213 0
Email 13213 0
[email protected]
Contact person for scientific queries
Name 4141 0
Dr Natalie de Morton
Address 4141 0
Northern Health
35 Johnstone st
Broadmeadows 3047
Vic
Country 4141 0
Australia
Phone 4141 0
61 3 8345 5172
Fax 4141 0
Email 4141 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.