Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000264987
Ethics application status
Approved
Date submitted
23/02/2011
Date registered
11/03/2011
Date last updated
31/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing disability in older Australians through secondary stroke prevention.
Scientific title
A randomised controlled trial to investigate the effectiveness of a model of integrated, evidence based management of modifiable cardiovascular risk factors and post stroke depression, in stroke survivors returning to the care of their general practitioner.
Secondary ID [1] 259664 0
Nil
Universal Trial Number (UTN)
U1111-1119-5789
Trial acronym
ICARUSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke Prevention 261233 0
Post stroke Depression 261234 0
Condition category
Condition code
Stroke 259379 259379 0 0
Ischaemic
Stroke 259380 259380 0 0
Haemorrhagic
Mental Health 259393 259393 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Nurse coordinated evidence based quarterly follow up of participants in the community, in a shared care relationship between hospital based stroke specialists and community based primary care physicians. Each quarterly intervention includes a pre-visit semi structured telephone interview to assess risk factors and post stroke depression. Based on the pre-visit interview, a report is faxed to the Gp prior to the patient visit. The patient and Gp meet and complete an individualised risk factor worksheet including relevant diagnostic tests. The completed worksheet is returned to the coordinating hospital to facilitate potential shared care. Therefore, coordinated visits to the patients Gp in the first year following the index stroke.
2. Simultaneously, over the period of 1-year, participants receive risk stratified telemedicine follow-up from the nurse coordinator that includes, education and support. As calculated by a study specific risk calculation algorithm, risk is assigned as high, medium or low. High risk participants are exposed to a greater frequency of telephone follow-up i.e., weekly for 3 months, 3-weekly for 3-months and monthly for 6-months. Low risk participants receive monthly telephone calls. The frequency may be modified according to changes in individual patient needs. Components of telephone calls include a range of established behavioral modification strategies to target health related lifestyle modification, plus health education, carer support, medication compliance and the potential for referral for specialist support.
Intervention code [1] 258092 0
Prevention
Intervention code [2] 258093 0
Behaviour
Intervention code [3] 258094 0
Lifestyle
Comparator / control treatment
Standard treatment or usual care. Participants are discharged to ongoing management by their Gp in the community, without nurse and specialist support as outlined above. Participant outcomes are followed-up at 1-year following the index stroke event.
Control group
Active

Outcomes
Primary outcome [1] 262197 0
A significant reduction in the intervention group for the composite endpoint of stroke, myocardial infarction and death. Data will be collected at outcome patient interview and through review of health records.
Timepoint [1] 262197 0
One year post index event.
Secondary outcome [1] 273304 0
Risk factor management by general practitioners. We will compare the achievement of international recommendations for conventional quantifiable stroke risk factor management in the two groups i.e. hypertension, cholesterol level, diabetic state, atrial fibrillation, degree of anti-coagulation and smoking. Diagnostic results will be collected at 1-year from both control and intervention Gp's records and through outcome participant interview.
Timepoint [1] 273304 0
One year post index event
Secondary outcome [2] 273305 0
Management of stroke survivors in the community. We will generate the scores from a series of structured assessments on functional status (Modified Rankin Scale, Barthel Index, Social Functioning Examination), cognitive and speech ability (Modified Mini Mental State Examination, Frenchay Aphasia Screening Test), depression (Person Health Questionnaire-9), quality of life (Assessment of Quality of Life), as well as consumer and practitioner satisfaction and access to services in the community via study specific data collection tools.
Timepoint [2] 273305 0
One year post index event.

Eligibility
Key inclusion criteria
1. Diagnosis of stroke (ischemic or hemorrhagic) or transient ischemic attack.
2. Returning to the care of the primary care physician upon discharge from acute care or rehabilitation.
3. Is able to provide informed consent.
4. 18 years of age or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosed with dissection, subarachnoid hemorrhage, traumatic intracerebral hemorrhage or subdural hematoma.
2. Unable to return to the care of their primary care physician.
3. Unable to provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stroke patients admitted to stroke units of metropolitan hospitals will be screened for eligibility, then approached to provide informed consent for a period up to 3-months from the index event. The stroke coordinator will identify the patients General Practitioner (Gp) and assign the Gp a study specific number. This number will be used to randomise the Gp and patient to either intervention or control group using an independent voice randomisation service (IVRS). Only Gp's randomised to the intervention will be contacted by study staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by centre (Gp) using a small block design to avoid unbalancing the sample.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3638 0
3050
Recruitment postcode(s) [2] 3639 0
3065
Recruitment postcode(s) [3] 3640 0
6000
Recruitment postcode(s) [4] 3641 0
3121
Recruitment postcode(s) [5] 3642 0
2310
Recruitment postcode(s) [6] 3643 0
3050

Funding & Sponsors
Funding source category [1] 258553 0
Charities/Societies/Foundations
Name [1] 258553 0
The HCF Health and Medical Research Foundation
Country [1] 258553 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Ageing Research Institute (NARI) of Melbourne.
Address
Gate 4, 34-54 Poplar Road Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 257690 0
University
Name [1] 257690 0
The University of Melbourne
Address [1] 257690 0
Grattan St Parkville, VIC 3010
Country [1] 257690 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260522 0
Melbourne Health Office for Research
Ethics committee address [1] 260522 0
Ethics committee country [1] 260522 0
Australia
Date submitted for ethics approval [1] 260522 0
12/04/2007
Approval date [1] 260522 0
16/05/2007
Ethics approval number [1] 260522 0
2007.078

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

Contacts
Principal investigator
Name 32260 0
Address 32260 0
Country 32260 0
Phone 32260 0
Fax 32260 0
Email 32260 0
Contact person for public queries
Name 15507 0
David Jackson
Address 15507 0
Department of Neurology
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Australia
Country 15507 0
Australia
Phone 15507 0
+61 3 9342 7598
Fax 15507 0
+61 3 9342 7444
Email 15507 0
[email protected]
Contact person for scientific queries
Name 6435 0
Dr Jacques Joubert
Address 6435 0
National Ageing Research Institute (NARI)
PO Box 2127
Royal Melbourne Hospital
Parkville Victoria 3050
Country 6435 0
Australia
Phone 6435 0
+61 419 790 448
Fax 6435 0
Email 6435 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.