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Trial registered on ANZCTR
Registration number
ACTRN12612001056886
Ethics application status
Approved
Date submitted
2/10/2012
Date registered
4/10/2012
Date last updated
4/10/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Nurse-led chronic disease care in Wheatbelt, Western Australia
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Scientific title
To investigate whether an intensive practice nurse led chronic heart and lung disease primary care in Wheatbelt general practices will reduce avoidable hospitalisations as compared to routine general practice care.
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Secondary ID [1]
281333
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Nil
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Universal Trial Number (UTN)
U1111-1135-3640
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
asthma
287554
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COPD
287555
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hypertension
287556
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heart disease
287564
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Condition category
Condition code
Public Health
287880
287880
0
0
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Health service research
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Cardiovascular
287881
287881
0
0
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Hypertension
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Respiratory
287890
287890
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be followed up three-monthly over a year. An individualised care plan will be formulated by the practice nurse with the participant in the initial consult (1 hour). This care plan will be reviewed every 3 months (0.5 hour each time). The care plan includes list of medication/s, list of medical condition/ medical history, dietary and lifestyle advice, what to do in medical emergency e.g. acute asthma attack.
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Intervention code [1]
285796
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Lifestyle
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Intervention code [2]
285803
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Treatment: Other
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Intervention code [3]
285804
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Prevention
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Comparator / control treatment
Routine practice: ad hoc care
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Control group
Active
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Outcomes
Primary outcome [1]
288098
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Number of avoidable hospitalisation for asthma, COPD and hypertension in test and control sites during the intervention period using regional hospital morbidity and mortality dataset
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Assessment method [1]
288098
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Timepoint [1]
288098
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3 monthly over a year
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Secondary outcome [1]
299426
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Quality of Life as assessed by the SF-12 questionnaire
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Assessment method [1]
299426
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Timepoint [1]
299426
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3 monthly over a year
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Secondary outcome [2]
299427
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Chronic Respiratory Questionnaire
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Assessment method [2]
299427
0
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Timepoint [2]
299427
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3 monthly over a year
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Eligibility
Key inclusion criteria
able to give informed consent; have a heart and/or lung chronic disease currently managed in primary care
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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
Unable to give informed consent; chronic condition not well controlled or need intensive treatment; deemed not suitable for participation by treating clinicians; participants want to withdraw from the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Information sheets for the study are made available at the reception area of each participating general practice. Willing participants send signed consent form to researchers. Participants are screened by nurse whether they fully understand the purpose and scope of the intervention. An individualised care plan is formulated with the respective participant.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randmised
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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
Mixed methods: embedded QUAN(qual) with focus group conducted with willing informants (not necessarily participants of the study)
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Phase
Not Applicable
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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
1/11/2012
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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
160
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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]
286100
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Government body
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Name [1]
286100
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State Health Research Advisory Council (SHRAC) Translational Research
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Address [1]
286100
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189 Royal St
East Perth WA 6004
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Country [1]
286100
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Wheatbelt GP Network
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Address
PO Box 781 (15 Elizabeth Place)
Northam WA 6401
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Country
Australia
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Secondary sponsor category [1]
284912
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Government body
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Name [1]
284912
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WA Country Health Services
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Address [1]
284912
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PO Box 5147 (125 Grey Street West)
Albany WA 6330
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Country [1]
284912
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288147
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Royal Australian College of General Practitioners
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Ethics committee address [1]
288147
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1 Palmerston Crescent,
South Melbourne, VIC 3205
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Ethics committee country [1]
288147
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Australia
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Date submitted for ethics approval [1]
288147
0
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Approval date [1]
288147
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24/02/2012
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Ethics approval number [1]
288147
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NREEC11
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Ethics committee name [2]
288151
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WA Country Health Service
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Ethics committee address [2]
288151
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61 Victoria Street,
Bunbury, WA 6230
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Ethics committee country [2]
288151
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Australia
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Date submitted for ethics approval [2]
288151
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Approval date [2]
288151
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23/03/2012
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Ethics approval number [2]
288151
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2012:03
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Summary
Brief summary
To compare whether a nurse-led model of chronic disease care in rural general practice will reduce unwanted hospitalisation
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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
34785
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Address
34785
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Country
34785
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Phone
34785
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Fax
34785
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Email
34785
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Contact person for public queries
Name
18032
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David Lim
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Address
18032
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PO Box 781 (15 Elizabeth Place)
Northam, WA 6401
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Country
18032
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Australia
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Phone
18032
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+61,8,96211530
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Fax
18032
0
+61,8,96211532
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Email
18032
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[email protected]
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Contact person for scientific queries
Name
8960
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David Lim
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Address
8960
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PO Box 781 (15 Elizabeth Place)
Northam, WA 6401
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Country
8960
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Australia
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Phone
8960
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+61,8,96211530
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Fax
8960
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+61,8,96211532
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Email
8960
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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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