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ISRCTN
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ISRCTN42132522
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ClinicalTrials.gov identifier
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Public title
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Determining the optimal approach to identifying individuals with chronic obstructive pulmonary disease
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Scientific title
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Determining the optimal approach to identifying individuals with chronic obstructive pulmonary disease: a multi-centre randomised trial
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Acronym
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DOC study
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Serial number at source
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N/A
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Study hypothesis
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1. To identify the most effective case-finding pathway for chronic obstructive pulmonary disease (COPD). The specific health service impacts across different possible pathways for undertaking COPD case finding amongst current smokers in primary care settings will be assessed.
2. To assess the cost-effectiveness of COPD case-finding pathways. A cost-per-true-positive-case-found analysis will be undertaken and health care resource use will be incorporated.
3. To evaluate the efficiency of the ‘case finding’ pathway. Key factors to consider will be the quality of the forced expiratory volume in one second (FEV1)/forced vital capacity (FVC), mechanical peak expiratory flow rate (PEFR) measurements and wheezometer measurements (in relation to the reference standard).
4. To evaluate whether undergoing the diagnostic test(s) has an impact on smoking behaviour to inform future smoking cessation studies.
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Lay summary
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Ethics approval
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Approval from the Newcastle and North Tyneside 2 Research Ethics Committee was received on 29th July 2010 (Ref: 10/H0907/37)
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Study design
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Multi-centre randomised trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic obstructive pulmonary disease (COPD)
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Participants - inclusion criteria
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Current smokers aged 35 years or more who are registered with participating GP practices
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Participants - exclusion criteria
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1. Pregnancy
2. Recent history (within 8 weeks) of myocardial infarction, stroke, pulmonary embolism, chest/abdominal surgery or eye surgery
3. Any mental or physical condition (e.g. chest/ abdominal pain/ stress incontinence) or any other condition which means the participant is unable to undergo the case-finding tools
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Anticipated start date
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01/05/2011
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Anticipated end date
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31/07/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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600
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Interventions
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1. Participants will undertake lung function tests (i.e. peak flow measurement, microspirometry and post-bronchodilator spirometry), a wheeze-detecting device (i.e. wheezometer) and a case-finding questionnaire
2. Further questionnaires will be completed during the study; a screening questionnaire and a follow-up questionnaire.
All participants receive the case-finding tests, with half randomised to receive the tests straight away and the remainder will receive the tests approximately 6 months later.
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Primary outcome measure(s)
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Effectiveness of diagnostic pathways – aim to identify the most effective pathway for use as the routine service model in primary care
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Secondary outcome measure(s)
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1. Cost-effectiveness of COPD case-finding pathway
2. Efficiency of COPD case-finding pathway
3. Impact on smoking behaviour
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Sources of funding
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Department of Health (UK)-Respiratory Programme
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Trial website
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Publications
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Contact name
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Mrs
Lisa
Dyson
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Address
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York Trials Unit
Ground Floor ARRC Building
Department of Health Sciences
University of York
Heslington
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Email
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lisa.dyson@york.ac.uk
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Sponsor
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University of York (UK)
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Address
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c/o Sue Final
Innovation Centre
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Email
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sue.final@york.ac.uk
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Sponsor website:
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http://www.york.ac.uk/
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Date applied
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22/02/2011
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Last edited
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31/03/2011
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Date ISRCTN assigned
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31/03/2011
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