Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000091606
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
28/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Systematic practice-based asthma care in the Australian setting
Scientific title
A cluster randomised controlled trial to evaluate the impact of systematic asthma care in Australian general practice on patient health outcomes, quality of care and cost effectiveness
Universal Trial Number (UTN)
Trial acronym
SPBAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 171 0
Condition category
Condition code
Respiratory 191 191 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of systematic care at the practice level. Systematic care includes asthma register, recall of patients, GP and staff education and quality assurance. Intervention takes place over 12 month period.
Intervention code [1] 92 0
Treatment: Other
Comparator / control treatment
Usual care.
Control group
Active

Outcomes
Primary outcome [1] 231 0
Clinical outcomes (eg waking weekly with asthma)
Timepoint [1] 231 0
Measured at 6 mths and 12 months.
Primary outcome [2] 232 0
Quality of care (eg preparation of written asthma action plan)
Timepoint [2] 232 0
Measured at 6 mths and 12 months.
Secondary outcome [1] 520 0
Quality of life
Timepoint [1] 520 0
Measured at 6 mths and 12 mths, except acceptability at 12 mths only.
Secondary outcome [2] 521 0
Patient ability to self-manage
Timepoint [2] 521 0
Measured at 6 mths and 12 mths, except acceptability at 12 mths only.
Secondary outcome [3] 522 0
Cost-effectiveness
Timepoint [3] 522 0
Measured at 6 mths and 12 mths, except acceptability at 12 mths only.
Secondary outcome [4] 523 0
Acceptability of system to practices and patients.
Timepoint [4] 523 0
Measured at 6 mths and 12 mths, except acceptability at 12 mths only.

Eligibility
Key inclusion criteria
Diagnosed with moderate or severe asthma.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If unable to read and understand English; other major illnesses; significant cognitive impairment.

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)
Randomisation not performed until all practices and patients recruited. Practices randomised by a third party
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation at the practice level, within 4 strata (SA/NSW x urban/rural) with no blocking, using random numbers generated by SAS version 9.1
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinding of data collectors and data analysts
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
880
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 248 0
Government body
Name [1] 248 0
National Health and Medical Research Council of Australia
Country [1] 248 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
MDP 33, GPO Box 9848
CANBERRA ACT 2601
Country
Australia
Secondary sponsor category [1] 189 0
None
Name [1] 189 0
None
Address [1] 189 0
Country [1] 189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1049 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 1049 0
Ethics committee country [1] 1049 0
Australia
Date submitted for ethics approval [1] 1049 0
Approval date [1] 1049 0
Ethics approval number [1] 1049 0
Ethics committee name [2] 1050 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [2] 1050 0
Ethics committee country [2] 1050 0
Australia
Date submitted for ethics approval [2] 1050 0
Approval date [2] 1050 0
Ethics approval number [2] 1050 0

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

Contacts
Principal investigator
Name 35649 0
Address 35649 0
Country 35649 0
Phone 35649 0
Fax 35649 0
Email 35649 0
Contact person for public queries
Name 9281 0
Ms Chris Holton
Address 9281 0
Department of General Practice
University of Adelaide
Adelaide SA 5005
Country 9281 0
Australia
Phone 9281 0
+61 8 83036268
Fax 9281 0
+61 8 83033511
Email 9281 0
christine.holton@adelaide.edu.au
Contact person for scientific queries
Name 209 0
Prof Justin Beilby
Address 209 0
Faculty of Health Sciences
University of Adelaide
Adelaide SA 5005
Country 209 0
Australia
Phone 209 0
+61 8 83035193
Fax 209 0
+61 8 83033788
Email 209 0
justin.beilby@adelaide.edu.au

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.