Trial from ANZCTR


Trial ID ACTRN12611000264987
Trial Status: Registered
Date Submitted: 23/02/2011
Date Registered: 11/03/2011
Retrospectively registered

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Public title Reducing disability in older Australians through secondary stroke prevention.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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Secondary ID [1] 259664 0
Nil
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UTN U1111-1119-5789
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Trial acronym ICARUSS
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Health condition(s) or problem(s) studied:
Stroke Prevention 261233 0
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Post stroke Depression 261234 0
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Condition category: Condition code:
Stroke Ischaemic
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Stroke Haemorrhagic
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Mental Health Depression
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Descriptions 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.
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Intervention Code:
Prevention 258092 0
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Behaviour 258093 0
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Lifestyle 258094 0
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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.
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Control group Active
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Primary Outcome: 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. 262197 0
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Timepoint: One year post index event. 262197 0
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Secondary Outcome: 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. 273304 0
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Timepoint: One year post index event 273304 0
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Secondary Outcome: 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. 273305 0
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Timepoint: One year post index event. 273305 0
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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
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s)
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 26/02/2008
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 300
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 3050 3638 0
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Postcode: 3065 3639 0
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Postcode: 6000 3640 0
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Postcode: 3121 3641 0
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Postcode: 2310 3642 0
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Postcode: 3050 3643 0
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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 258553 0
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Name: The HCF Health and Medical Research Foundation 258553 0
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Address: Level 6, 403 George Street, Sydney NSW 2000 258553 0
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Country: Australia 258553 0
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Primary Sponsor Charities/Societies/Foundations
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Name: National Ageing Research Institute (NARI) of Melbourne.
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Address: Gate 4, 34-54 Poplar Road Parkville Victoria 3052
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Country: Australia
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Secondary Sponsor: University 257690 0
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Name: The University of Melbourne 257690 0
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Address: Grattan St Parkville, VIC 3010 257690 0
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Country: Australia 257690 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Melbourne Health Office for Research 260522 0
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Address: The Office for Research
The Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
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Country: Australia 260522 0
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Approval Date: 16/05/2007 260522 0
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Submitted Date: 12/04/2007 260522 0
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HREC: 2007.078 260522 0
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Brief summary Stroke survivors can be faced with many problems including the physical disability resulting from the stroke, interruption and often cessation of gainful employment, disruption to family life and the onset of post stroke depression. Stroke survivors are also at a much higher risk of experiencing further stroke. Effective management of stroke risk factors including, high blood pressure, high cholesterol, smoking, excessive alcohol intake and obesity, can significantly reduce the likelihood of a recurrent stroke. However, there remains a considerable gap between published and evidence-based guidelines for stroke prevention and the reality of care received by stroke survivors.

The Integrated CAre for the RedUction of Secondary Stroke Project (ICARUSS) is an integrated, multi-modal model of care for the management of risk factors in stroke survivors that was developed from a shared care model. Its goal is to reduce mortality and disability by reducing the recurrence of stroke. Initial results of a pilot study suggest that it is practical, feasible and of great importance to stroke survivors, there carers, and the community in general. The model is now being tested on a broader scale throughout Australia.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: David Jackson
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Address: Department of Neurology Royal Melbourne Hospital Grattan St Parkville VIC 3050 Australia
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Tel: +61 3 9342 7598
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Fax: +61 3 9342 7444
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Email: david.jackson@mh.org.au
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Contact person for scientific queries
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Name: Dr Jacques Joubert
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Address: National Ageing Research Institute (NARI) PO Box 2127 Royal Melbourne Hospital Parkville Victoria 3050
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Country: Australia
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Tel: +61 419 790 448
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Email: jjoubertneuro@gmail.com
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Contact person responsible for updating information
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Name: David Jackson
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Address: Department of Neurology Royal Melbourne Hospital Grattan St Parkville VIC 3050 Australia
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Country: Australia
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Tel: +61 3 9342 7598
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Email: david.jackson@mh.org.au
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Addition Cancer fields
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