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ISRCTN
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ISRCTN72258018
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ClinicalTrials.gov identifier
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Public title
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An evaluation of the cost effectiveness of single test screening spirometry in the early diagnosis and management of Chronic Obstructive Pulmonary Disease (COPD) in primary care
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0375126454
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Study hypothesis
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Does knowledge of an abnormal spirometry result significantly improve smoke stop rates for smokers aged 35-75?
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled 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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Respiratory: Chronic obstructive pulmonary disease (COPD)
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Participants - inclusion criteria
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All smokers with 20 pack years plus, aged between 35 and 75, presenting in primary care to the HTQ Programme will be eligible for entry into the trial. All subjects recruited to the HTQ programme who fulfill the eligibility criteria will be invited to take part in the study.
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Participants - exclusion criteria
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1. Eg breathlessness
2. Terminally ill
3. Subjects with prior knowledge of spirometry status
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Anticipated start date
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01/06/2002
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Anticipated end date
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01/06/2004
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Subjects will be recruited opportunistically in primary care. On average each practice is expected to recruit between 80-90 individuals. Subjects who accept will then be randomised to receive or not receive spirometry at the start of the HTQ programme. Both groups will be assessed on generic quality of life (QoL) and anxiety. Practice nurses will be trained and administer all questionnaires and tests, for which they will receive a payment. At 12 months subjects in both groups will be reviewed and receive spirometry and repeat QoL and anxiety questionnaires.
Please note, this trial was stopped due to lack of funding.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Shrewsbury and Telford Research and Development Consortium (UK)
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Trial website
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Publications
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Contact name
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Dr
M
Innes
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Address
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Stirchley Medical Practice
Sandino Road
Stirchley
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City/town
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Telford
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Zip/Postcode
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TF3 1FB
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Country
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United Kingdom
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Tel
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+44 (0)1952 660444
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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01/11/2011
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Date ISRCTN assigned
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30/09/2004
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