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ISRCTN
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ISRCTN34254423
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ClinicalTrials.gov identifier
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Public title
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Pilot trial to assess the feasibility and response rates for an RCT evaluating the effectiveness of a computer tailored intervention for smoking cessation in general practice
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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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N0530137082
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Study hypothesis
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The aim of the proposed research is to carry out a pilot study to assess the feasibility of, and response rates to, an intervention for smoking cessation. We have already developed a computer-based system for generating individually tailored feedback reports designed to encourage and help smokers to quit. These self-help materials tailored for each individual mimic the care used in clinical settings, but make this available to the general public. We plan to adapt this system for use in general practice, modifying the questionnaire and the feedback reports to different educational levels. The pilot work will lead to a large RCT evaluating the effectiveness of the intervention. The hypothesis to be tested on smokers identified from general practitioners lists is that: Personalised feedback reports tailored to levels of reading ability and sent to smokers in varying stages of readiness to quit, will increase quitting activity and modify the attitudes of the smokers over and above that found with usual standard care received from the practice.
Please note that this trial was completed on the 30th June 2005. The previous end date for this pilot study was 31/05/2009. The main RCT of this pilot study has been registered under ISRCTN05385712 (see http://www.controlled-trials.com/ISRCTN05385712).
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Lay summary
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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 - pilot study
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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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Smoking addiction
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Participants - inclusion criteria
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1. Smokers
2. Aged between 18 and 65 years, either sex
3. Identified from records in four practices
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Participants - exclusion criteria
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Does not comply with above inclusion criteria
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Anticipated start date
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01/01/2004
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Anticipated end date
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30/06/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Four General Practices. 200 participants will be selected from each practice = 800 in total.
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Interventions
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Questionnaires; Before-After-Study, Randomised Controlled Trial (RCT) comparison between:
1. Normal treatment
2. Normal treatment plus tailored feedback reports group
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Primary outcome measure(s)
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Computer tailored feedback, adapted to reading levels and readiness to quit, is a simple intervention which could be widely replicated and delivered cost effectively to a large proportion of the smoking population. A modest success rate could have a large effect on public health given its recruitment potential and make a valuable contribution to lowering smoking prevalence. The method mimics the guidelines of asking, advising, assessing, assisting and arranging and could be incorporated into GPs standard treatment at less time and cost. These materials, tailored to the requirements of each individual, would offer GPs and practice nurses an efficient way of integrating smoking cessation counselling into a busy primary care practice. The computer programme could also be made available on CD Rom to produce immediate printed feedback for use by primary care professionals.
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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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North Central London Research Consortium (UK)
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Trial website
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Publications
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2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17584974
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Contact name
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Dr
Hazel
Gilbert
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Address
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University College London
Department of Epidemiology
2-16 Torrington Place
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City/town
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London
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Zip/Postcode
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WC1E 6BT
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Country
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United Kingdom
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Tel
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+44 (0)20 7679 1606
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Fax
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+44 (0)20 7813 2848
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Email
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hazel.gilbert@ucl.ac.uk
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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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01/04/2008
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Date ISRCTN assigned
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30/09/2004
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