Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000378527
Ethics application status
Approved
Date submitted
11/08/2006
Date registered
29/08/2006
Date last updated
29/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of spirometry (lung function testing) in the management of chronic respiratory diseases (asthma and COPD) in general practice to improve quality of life.
Scientific title
The role of spirometry in managing chronic respiratory diseases in general practice to improve quality of life.
Universal Trial Number (UTN)
Trial acronym
SPIRO-GP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic respiratory diseases - asthma and chronic obstructive pulmonary disease (COPD) 1345 0
Condition category
Condition code
Respiratory 1434 1434 0 0
Asthma
Respiratory 1435 1435 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a Double Blind Randomised Controlled Trial ( RCT) where practices are randomly allocated to:
- Group 1 ( intervention with spirometry) For 12 months practices will receive full spirometry intervention and an interpretation of results will be notified to the treating GP
-Group 2 (intervention without spirometry) For 12 months practices will receive spirometry before and after the trial, but no results will be reported to the GP
Intervention code [1] 1305 0
Other interventions
Comparator / control treatment
Group 3 (Control) For 12 months practices will provide usual medical care only, which may include peak flow monitoring, but not spirometry
Control group
Active

Outcomes
Primary outcome [1] 1971 0
Quality of Life using the 'Short Form 36' (SF36) questionnaire
Timepoint [1] 1971 0
Measured at baseline, 3, 6, 9, and 12 months
Primary outcome [2] 1972 0
Asthma Control utilising the validated Juniper questionnaire
Timepoint [2] 1972 0
Measured at baseline, 3, 6, 9, and 12 months
Secondary outcome [1] 3433 0
Frequency of symptoms, written management plans and medications.
Timepoint [1] 3433 0
Collated and assessed at baseline, 3,6, 9 and 12 months.
Secondary outcome [2] 3434 0
Emergency presentations to GP or Emergency Department, Hospital Admissions will be recorded and linked to Victorian Department of Human Services (DHS) Victorian Emergency Minimum Dataset (VEMD)and to the Victorian Admitted Episodes Dataset (VAED).
Timepoint [2] 3434 0
Secondary outcome [3] 3435 0
Change in Forced Expiratory Volume in one second (FEV1).
Timepoint [3] 3435 0
Measured and compared at baseline, 3, 6, 9, and 12 months ( Groups 1) and at Baseline and 12months ( Group 2 ).

Eligibility
Key inclusion criteria
General Practices will be included if there is a commitment by the practice to participate, they agree to randomisation, are willing to recruit patients with asthma or COPD from their practices, and are willing to search their medical records database (database search training will be provided to staff if required). Eligible patients will attend a general practice on the list of divisions of general practice in Melbourne and surrounding regions.
Patient inclusion criteria: attend a general practice on the list of Divisions of general Practice in Melbourne and surrounding regions, have doctor diagnosed asthma or COPD, must be able to understand English and must be able to provide written consent to participate.
Minimum age
7 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient exclusion criteria: are not contactable by phone, cannot speak or read English, are participating in another study involving asthma or COPD, have infrequent episodic asthma as defined by National Asthma Council (NAC) classification of childhood asthma, or other reason such as complex medical conditions eg. mental illness or cancer.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
three armed design - chosen because of a desire to investigate Forced Expiratory Volume in one second (FEV1) as a secondary outcome but concern about possible Hawthorne effects from participants attending a testing centre and having spirometry performed. The intervention will be concealed from GP's up to the time of recruitment and will be kept masked from patients and research staff performing oucome assessments.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
726
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1566 0
Government body
Name [1] 1566 0
NH&MRC
Country [1] 1566 0
Australia
Primary sponsor type
University
Name
Monash UniversityDepartment of Epidemiology & Preventive Medicine
Address
Country
Australia
Secondary sponsor category [1] 1378 0
University
Name [1] 1378 0
Melbourne University Department of General Practice
Address [1] 1378 0
Country [1] 1378 0
Australia
Secondary sponsor category [2] 1379 0
Hospital
Name [2] 1379 0
The Alfred
Address [2] 1379 0
Country [2] 1379 0
Australia
Secondary sponsor category [3] 1380 0
Charities/Societies/Foundations
Name [3] 1380 0
The Respiratory Alliance
Address [3] 1380 0
Country [3] 1380 0
Australia
Secondary sponsor category [4] 1381 0
Charities/Societies/Foundations
Name [4] 1381 0
The Whitehorse Division of General Practice and Pulmetrics
Address [4] 1381 0
Country [4] 1381 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2999 0
Monash University Standing Committee on Ethics in research Involving Humans
Ethics committee address [1] 2999 0
Ethics committee country [1] 2999 0
Australia
Date submitted for ethics approval [1] 2999 0
Approval date [1] 2999 0
07/12/2005
Ethics approval number [1] 2999 0
2005/825
Ethics committee name [2] 3000 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [2] 3000 0
Ethics committee country [2] 3000 0
Australia
Date submitted for ethics approval [2] 3000 0
Approval date [2] 3000 0
23/01/2006
Ethics approval number [2] 3000 0
050947

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

Contacts
Principal investigator
Name 27755 0
Address 27755 0
Country 27755 0
Phone 27755 0
Fax 27755 0
Email 27755 0
Contact person for public queries
Name 10494 0
Ms Rosa Schattner
Address 10494 0
Monash University Department of Epidemiology & Preventive Medicine, 89 Commercial Road Melbourne VIC 3004
Country 10494 0
Australia
Phone 10494 0
99030995
Fax 10494 0
99030556
Email 10494 0
[email protected]
Contact person for scientific queries
Name 1422 0
Professor Michael Abramson
Address 1422 0
Monash University Department of Epidemiology & Preventive Medicine, 89 Commercial Road Melbourne VIC 3004
Country 1422 0
Australia
Phone 1422 0
99030555
Fax 1422 0
99030556
Email 1422 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
No additional documents have been identified.