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Trial registered on ANZCTR
Registration number
ACTRN12607000334404
Ethics application status
Approved
Date submitted
18/06/2007
Date registered
21/06/2007
Date last updated
21/08/2007
Type of registration
Prospectively registered
Titles & IDs
Public title
The feasibility, acceptability and cost-effectiveness of nurse-led models of chronic disease management in general practice
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Scientific title
A comparison of the feasibility, acceptability and cost-effectiveness of a nurse-led collaborative care model versus the normal General Practitioner care model of chronic disease management in three general practice locations.
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Universal Trial Number (UTN)
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Trial acronym
Nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type II diabetes
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Hypertension
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Ischemic heart disease
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Condition category
Condition code
Metabolic and Endocrine
1978
1978
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0
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Diabetes
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Cardiovascular
1979
1979
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0
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Hypertension
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Cardiovascular
1980
1980
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention = patients in primary care who are having their chronic disease (diabetes Type II, hypertension or ischemic heart disease) managed by a PN. This means that a PN will manage these patients, following protocols for each disease. The patient will only see the GP if the PN has a concern regarding the patient’s condition or if the patient requests this. Otherwise, all management will be undertaken by the PN.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
Control = patients in primary care who are having their chronic disease (diabetes Type II, hypertension or ischemic heart disease) managed as usual by their GP within their general practice.
The intervention will last for 18 months.
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Control group
Active
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Outcomes
Primary outcome [1]
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Any change in health related quality of life and health status to patients with chronic disease in the PN-led arm of the project.
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Assessment method [1]
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Timepoint [1]
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A minimum of six monthly intervals
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Primary outcome [2]
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An assessment of patient satisfaction, confidence and ‘acceptability’ of this model.
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Assessment method [2]
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Timepoint [2]
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Before and after the intervention
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Primary outcome [3]
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The use of PNs to decrease the GP’s caseload of patients with chronic illness
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Assessment method [3]
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Timepoint [3]
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At completion of the study – 18 months
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Primary outcome [4]
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Estimate the costs and any cost-savings to patients, general practices and the government, and identify any shifts of costs between these and other institutions in the health sector.
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Assessment method [4]
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Timepoint [4]
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At completion of the study – 18 months
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Secondary outcome [1]
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Improvement of professionals’ adherence to protocols
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Assessment method [1]
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Timepoint [1]
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At completion of the study – 18 month
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Secondary outcome [2]
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Patients, GPs and nurses are satisfied with a nurse-led model
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Assessment method [2]
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Timepoint [2]
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At completion of the study – 18 month
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Secondary outcome [3]
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Impact, if any, of a nurse-led model of care on the number of visits needed by patients to general practitioners, hospital admissions and after hours presentations
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Assessment method [3]
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Timepoint [3]
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At completion of the study – 18 month
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Secondary outcome [4]
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The PN model has an impact on teamwork and collaboration in a general practice
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Assessment method [4]
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Timepoint [4]
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At completion of the study – 18 month
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Secondary outcome [5]
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Provide information on whether this model helps address the systemic impediments to current health workforce models and make recommendations on its progression.
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Assessment method [5]
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Timepoint [5]
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At completion of the study – 18 month
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Secondary outcome [6]
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Estimate the costs and any cost-savings to patients, general practices and the government, and identify any shifts of costs between these and other institutions in the health sector.
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Assessment method [6]
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Timepoint [6]
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At completion of the study – 18 month
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Eligibility
Key inclusion criteria
Patients who are currently being managed for Diabetes Type II, Hypertension, Ischemic Heart DiseasePatients with heart disease (angina, following MI) included in the intervention arm must be twelve months post acute incidence.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Each General Practitioner can decide if a patient is deemed unsuitable for management through this study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by central randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation conducted externally. Stratified allocation was also used. Participants were stratified according to disease type i.e. diabetes type II, hypertension, ischemic heart disease.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
750
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Research Council (ARC) Discovery Grant
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Address [1]
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Canberra
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Department of Nursing and Midwifery, Research and Practice Development Centre, University of Queensland and Blue Care.
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Nil
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Queensland
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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12/10/2004
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Ethics approval number [1]
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2004000718
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Ethics committee name [2]
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University of Southern Queensland
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Ethics committee address [2]
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
3911
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Approval date [2]
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04/10/2004
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Ethics approval number [2]
3911
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H04STU419
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Ethics committee name [3]
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Griffith University
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Ethics committee address [3]
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
3912
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Approval date [3]
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30/03/2007
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Ethics approval number [3]
3912
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NRS/08/07/HREC
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Ethics committee name [4]
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Bond University
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Ethics committee address [4]
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Ethics committee country [4]
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Australia
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Date submitted for ethics approval [4]
3913
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Approval date [4]
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12/02/2007
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Ethics approval number [4]
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R0633
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Summary
Brief summary
The feasibility, acceptability and cost-effectiveness of nurse-led models of chronic disease management in the Australian environment The aim of this project is to address significant gaps in the evidence for a practice nurse-led model of the management of patients with chronic disease in general practice. Our research questions are: 1) is it feasible from a systems perspective i.e., the impact of the changes on the service delivery of chronic disease management through primary care, 2) is it acceptable to key stakeholders as well as to patients/carers i.e., will the necessary changes associated with this model of care develop productive partnerships between health care providers stakeholders and consumers; 3) is it cost-effective within the current regulatory environment and 4) does it have an impact on patient health/quality of life? The chronic diseases to be managed in this study are diabetes Type II and cardio-vascular disease (hypertension and ischemic heart disease). Objectives of the Project: The study will determine if: a) the employment of a practice nurse (PN) in general practice to manage the day to day care of patients (and their carers) with chronic disease is feasible within the general practice environment. Issues to be considered will be the design of the general practice environment, the number of patient consultations per day, descriptions of the scope of practice of the nurse (are there education and legislative changes required to the scope of practice?). b) nurse-led patient care, rather than GP led care, is acceptable to: (i) patients and their carers (ii) staff within the general practice , General Practitioners (GPs), Practice Managers, other PNs) c) it is cost-effective. (i) does the employment of nurses in this capacity increase the number of patients who can be seen within general practice? (ii) is there any impact on the number of patients requiring after hours care (in hospital emergency departments as well as by the practice)? (iii) are waiting lists to see a general practitioner reduced within the practice? (iv) Is the current EPC model for Chronic Disease Management Plans sufficient payment to the practice for the employment of a practice nurse or are other models more cost-effective? The study duration will be 3 years, 12 months of which will comprise the comparison of the two models of care in each of the three participating general practices. The general practices have been purposively selected by their willingness to participate, the distance they are from each other (thus ensuring that patients would not visit one or more of the other practices), their rural classification, they are computerised and employ a PN. The general practices are: • The remote practice is Myall Medical Centre, Dalby Queensland • The rural general practice is Koinonia located in Toowoomba, Queensland • The regional practice is Kingscliff Medical Centre in Kingscliff NSW. This program addresses policy implications associated with the of role chronic disease as a national health priority, the huge burden of chronic disease and the statistical evidence of its growth. Finding better ways to manage these diseases are necessary to GPs who face increasing case loads of patients. This project will inform policy to establish such a role and ultimately improve chronic disease care within primary practice.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Professor Desley Hegney
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Address
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Research and Practice Development Centre
University of Queensland and Blue Care
PO Box 1539
Milton BC QLD 4064
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Country
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Australia
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Phone
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+61 7 37205302
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Fax
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+61 7 37205332
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Desley Hegney
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Address
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Research and Practice Development Centre
University of Queensland and Blue Care
PO Box 1539
Milton BC QLD 4064
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Country
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Australia
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Phone
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+61 7 37205302
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Fax
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+61 7 37205332
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Email
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[email protected]
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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.
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