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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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22 February 2013 |
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Main ID: |
ACTRN12606000378527 |
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Date of registration:
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29/08/2006 |
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Primary sponsor: |
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Public title:
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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.
SPIRO-GP study |
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Scientific title:
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The role of spirometry in managing chronic respiratory diseases in general practice to improve quality of life. |
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Date of first enrolment:
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21/03/2006 |
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Target sample size:
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726 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.anzctr.org.au/ACTRN12606000378527.aspx |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
Parallel |
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Countries of recruitment
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Australia
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Contacts
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Name:
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Professor Michael Abramson |
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Address:
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Monash University Department of Epidemiology & Preventive Medicine, 89 Commercial Road Melbourne VIC 3004, Australia
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Telephone:
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99030555 |
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Email:
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michael.abramson@med.monash.edu.au |
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Affiliation:
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Name:
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Ms Rosa Schattner |
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Address:
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Monash University Department of Epidemiology & Preventive Medicine, 89 Commercial Road Melbourne VIC 3004, Australia
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Telephone:
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99030995 |
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Email:
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rosa.schattner@med.monash.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
7 Years
Age maximum:
70 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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chronic respiratory diseases - asthma and chronic obstructive pulmonary disease (COPD)
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Intervention(s)
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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
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Primary Outcome(s)
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Asthma Control utilising the validated Juniper questionnaire
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Quality of Life using the 'Short Form 36' (SF36) questionnaire
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Secondary Outcome(s)
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Change in Forced Expiratory Volume in one second (FEV1).
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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).
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Frequency of symptoms, written management plans and medications.
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Source(s) of Monetary Support
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NH&MRC
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