Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001243909
Ethics application status
Approved
Date submitted
29/11/2011
Date registered
6/12/2011
Date last updated
6/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Establishing an effective and efficient Early Supported Discharge (ESD) rehabilitation program for Stroke clients in Perth WA
Scientific title
Providing an early home visit for mild-moderate severity strokes and facilitated discharge with the South Metro Area Health Service (SMAHS) Rehabilitation in the Home (RITH) therapists reduces length of stay for stroke unit patients in Perth WA: a randomised control trial.
Secondary ID [1] 273492 0
nil
Universal Trial Number (UTN)
U1111-1126-1811
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke rehabilitation 279280 0
early supported discharge 279281 0
Condition category
Condition code
Stroke 279478 279478 0 0
Ischaemic
Stroke 279479 279479 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
identification of stroke severity - individual assessment of stroke patients using the NIHSS on acute stroke unit admission. duration approximately 20-30 mins to complete
early home visit - joint home visit with ward and RITH therapists with the patient to assess home environment and patient requirements for safe discharge. duration 2-4 hours depending on home location and travel time
facilitated goal setting and discharge planning - after the early home visit the ward and RITH teharpist will jointly establish goals for early discharge with the patient and family and document this in the patients medical record.
RITH ESD team interface with ward based therapists - RITH therapist to visit the Stroke unit on a daily basis.
Intervention code [1] 283809 0
Rehabilitation
Comparator / control treatment
normal rehabilitation program on stroke unit and rehab unit if required - standard care. this consists of daily phsyiotherpay, occupational therapy, speech and language therapy as required by the patients. A multidisciplinary team approach to rehabilitation is conducted on the stroke unit. If the patient requires further inpatient rehabiliation a referral to one of several rehabilitation units will occur. Rehabiliation units provide intensive daily multidisciplinary rehabilitation.

As there is potential for a 'contamination effect' the intervention and control group (2011-2012) will also be compared to a historical dataset from Jan1st 2010 to Dec 31st 2010 to compare incidence of stroke, length of stay in the hospital setting, referral rate to SMAHS RITH and service event numbers.
Control group
Active

Outcomes
Primary outcome [1] 286045 0
The primary end point of the study is the functional outcome as assessed by the Lawtons Activity of Daily Living (Lawtons ADL) scale at 6months post discharge.
Timepoint [1] 286045 0
6 months post stroke admission
Primary outcome [2] 286046 0
The cost utility assessment will use the primary outcome relative to any observable changes to the LOS of the matched cohorts (plus a historical comparison).

the cost analysis will be the cost of the health care provided - system costs of stroke rehabiliation. ie: cost of inpatient care on a bedday cost versus cost of home based rehabilitation. there are no costs associated to the patient in monetary terms.
Patient and carer impact will be assessed using carer strain index and health realted quality of life. the study does not include the cost of home based community services and non-paid carer time.
Timepoint [2] 286046 0
over 12 month period
Secondary outcome [1] 295033 0
Functional independence measure (FIM)
measures patient functional level - activity level
Timepoint [1] 295033 0
6 months and 12 months post stroke admission
Secondary outcome [2] 295136 0
Modified Rankin
measures participation level
Timepoint [2] 295136 0
6 months and 12 months post stroke admission
Secondary outcome [3] 295137 0
Chedoke McMaster Postural control
measures impairment of motor control
Timepoint [3] 295137 0
6 months and 12 months post stroke admission
Secondary outcome [4] 295138 0
Lawtons ADL
measuring patient functional level in the community, activity level
Timepoint [4] 295138 0
6 months and 12 months post stroke admission
Secondary outcome [5] 295139 0
Carer strain index
measuring carer stress and burden
Timepoint [5] 295139 0
6 months and 12 months post stroke admission
Secondary outcome [6] 295140 0
SF12
health realted quality of life for patient
Timepoint [6] 295140 0
6 months and 12 months post stroke admission

Eligibility
Key inclusion criteria
- Resident in SMAHS catchment area (postcode)
- admitted to RPH Stroke unit
- mild/mod stroke as assessed on the NIHSS
- eligible for RITH program as per RITH criteria (including exclusion criteria for safe home visiting).
Minimum age
16 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known discharge destination not in the SMAHS RITH catchment area, i.e. rural patients
- Medically unstable for discharge to a home based service
- safety concerns for home visiting as per RITH SMAHS safe home visiting policy

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)
The study design is a randomised controlled trial with stratification based on initial severity of condition.

A retrospective cohort of data will be used to provide a historical benchmark on the length of stay (Primary outcome measure and economic analysis driver) related to gender age and the initial severity classification (Mild, Moderate).

Subjects will be allocated via a stratified randomisation process using sealed envelopes

Within each Large envelop there will be a number of smaller sealed non transparent envelopes. Each of these will have a card inside with one of three instructions:
Blank allocation – please open another envelop.
This person goes to the control group
This person goes to the EDS group.
Process.
Large envelopes will be initially sealed, numbered and allocated in order.
After the first 4 large envelopes have been completed, an audit of group allocation and dropouts will be examined by an investigator who is not active in assessments. This will be used to determine if there is a dropout bias present in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
From prior data (2010 7 months RPH) the ratio of Mild to Moderate NIHSS stroke admissions to RPH is 3:1. Therefore the stratification will be undertaken by the Mild: Moderate (NIHSS score) according to two block groups.
Each group will be randomised using a variable blocks.
Moderate blocks will be varied between 2, 3 and 4 active cards with each envelop having 4 cards in total. (1 and 2 blank cards in smaller blocks)
Mild blocks will be varied between 4, 5 and 6 active cards with each envelop having 6 cards in total. (1 and 2 blank cards in smaller blocks)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284282 0
Hospital
Name [1] 284282 0
Western Australian Department of Health State Health Research Advisory Council (WA DoH SHRAC) grant funding
Country [1] 284282 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hosptial (RPH)
Address
RPH
wellington ST
Perth
WA 6000
Country
Australia
Secondary sponsor category [1] 283234 0
None
Name [1] 283234 0
Address [1] 283234 0
Country [1] 283234 0
Other collaborator category [1] 260362 0
University
Name [1] 260362 0
Curtin university
Address [1] 260362 0
Curtin university
Kent St
Bentley
WA 6102
Country [1] 260362 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286241 0
RPH ethics committee
Ethics committee address [1] 286241 0
Ethics committee country [1] 286241 0
Australia
Date submitted for ethics approval [1] 286241 0
Approval date [1] 286241 0
18/10/2011
Ethics approval number [1] 286241 0
EC 2011/103

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

Contacts
Principal investigator
Name 33458 0
Address 33458 0
Country 33458 0
Phone 33458 0
Fax 33458 0
Email 33458 0
Contact person for public queries
Name 16705 0
roslyn Jones
Address 16705 0
C/o
RITH RPH
RPH outpatients building
RPH
198 goderich st
Perth
WA 6000
Country 16705 0
Australia
Phone 16705 0
+61864775152
Fax 16705 0
+61864775150
Email 16705 0
[email protected]
Contact person for scientific queries
Name 7633 0
roslyn Jones
Address 7633 0
C/o
RITH RPH
RPH outpatients building
RPH
198 goderich st
Perth
WA 6000
Country 7633 0
Australia
Phone 7633 0
+61864775152
Fax 7633 0
Email 7633 0
+61864775150

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.