Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000093583
Ethics application status
Approved
Date submitted
6/03/2006
Date registered
9/03/2006
Date last updated
27/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Spirometry and asthma management in children and adults in general practice.
Scientific title
A cluster randomised controlled trial to evaluate whether training of GPs and nurses in spirometry leads to improved health outcomes for children and adults with asthma, managed in general practice.
Universal Trial Number (UTN)
Trial acronym
SAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Management of spirometry in general practice.
 1057 0
Asthma. 1058 0
Condition category
Condition code
Respiratory 1138 1138 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comprehensive training for GPs and practice nurses in the intervention practices, in the performance and interpretation of spirometry, and encouragement to integrate spirometry use into their asthma management. The intervention will comprise a minimum of 6 hrs formal training, provided in the first 2 months after randomisation. Intervention practices will then apply this knowledge and be supported for the remainder of the 12-month study timeframe.
Intervention code [1] 929 0
Treatment: Other
Comparator / control treatment
Control practices will continue with usual care for their asthma patients for the 12 months of the study.
Control group
Active

Outcomes
Primary outcome [1] 1524 0
Improvements in health outcomes for patients with asthma, including quality of life.
Timepoint [1] 1524 0
Measured at 6 months and 12 months.
Primary outcome [2] 1525 0
Improvements in health outcomes for patients with asthma, including days off work/school
Timepoint [2] 1525 0
Measured at 6 months and 12 months.
Primary outcome [3] 1526 0
Improvements in health outcomes for patients with asthma, including number of emergency visits
Timepoint [3] 1526 0
Measured at 6 months and 12 months.
Primary outcome [4] 1527 0
Improvements in health outcomes for patients with asthma, including number of hospital admissions
Timepoint [4] 1527 0
Measured at 6 months and 12 months.
Primary outcome [5] 1528 0
Improvements in health outcomes for patients with asthma, including number of exacerbations
Timepoint [5] 1528 0
Measured at 6 months and 12 months.
Primary outcome [6] 1529 0
Improvements in health outcomes for patients with asthma, including other clinical indicators
Timepoint [6] 1529 0
Measured at 6 months and 12 months.
Secondary outcome [1] 2761 0
Improvements in the process of care provided to asthma patients, including use of spirometry, and provision of written asthma action plans.
Timepoint [1] 2761 0
Measured at 6 mths and 12 mths.
Secondary outcome [2] 2762 0
Acceptability by GPs, staff and patients, of the training in and use of spirometry.
Timepoint [2] 2762 0
Measured at 6 mths and 12 mths.
Secondary outcome [3] 2763 0
Cost-effectiveness of having practices perform spirometry.
Timepoint [3] 2763 0
Assessed at 12 mths.

Eligibility
Key inclusion criteria
A diagnosis of asthma and on asthma medication.
Minimum age
7 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
COPD, unable to read or 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)
Practices will be randomised by a third party, after all practices and patients have been recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation at the practice level, within 4 strata (SA/Tas x urban/rural) with no blocking, using random numbers generated by SAS.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1243 0
Government body
Name [1] 1243 0
NHMRC - General Practice Clinical Research Grant No. 349573
Country [1] 1243 0
Australia
Primary sponsor type
University
Name
The Discipline of General Practice, University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 1098 0
University
Name [1] 1098 0
The Discipline of General Practice, University of Tasmania
Address [1] 1098 0
Campbell Street
HOBART TAS 7000
Country [1] 1098 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2575 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 2575 0
Ethics committee country [1] 2575 0
Australia
Date submitted for ethics approval [1] 2575 0
Approval date [1] 2575 0
23/11/2005
Ethics approval number [1] 2575 0
H-131-2005
Ethics committee name [2] 2576 0
Human Research Ethics Committee (Tasmanian) Network
Ethics committee address [2] 2576 0
Ethics committee country [2] 2576 0
Australia
Date submitted for ethics approval [2] 2576 0
Approval date [2] 2576 0
27/02/2006
Ethics approval number [2] 2576 0
H0008708

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

Contacts
Principal investigator
Name 36078 0
Address 36078 0
Country 36078 0
Phone 36078 0
Fax 36078 0
Email 36078 0
Contact person for public queries
Name 10118 0
Ms Chris Holton
Address 10118 0
Primary Care Respiratory Unit
Discipline of General Practice
School of Population Health and Clinical Practice
University of Adelaide
Adelaide SA 5005
Country 10118 0
Australia
Phone 10118 0
+61 8 83036268
Fax 10118 0
+61 8 83033511
Email 10118 0
[email protected]
Contact person for scientific queries
Name 1046 0
Associate Professor Alan Crockett
Address 1046 0
Primary Care Respiratory Unit
Discipline of General Practice
School of Population Health and Clinical Practice
University of Adelaide
Adelaide SA 5005
Country 1046 0
Australia
Phone 1046 0
+61 8 83037504
Fax 1046 0
+61 8 83033511
Email 1046 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
SourceTitleYear of PublicationDOI
EmbaseSpirometry and regular follow-up do not improve quality of life in children or adolescents with asthma: Cluster randomized controlled trials.2015https://dx.doi.org/10.1002/ppul.23096
N.B. These documents automatically identified may not have been verified by the study sponsor.