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ISRCTN
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ISRCTN28602629
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ClinicalTrials.gov identifier
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Public title
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The use of audio tapes in oral health promotion for an Urdu speaking community
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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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RBF 99X23
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Study hypothesis
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Primary research question: Does the use of pre-recorded audio tapes encourage patients to complete their course of dental treatment.
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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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Oral health
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Participants - inclusion criteria
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The age group will be 6-10
Sample Size: The main outcome for determining sample size is failure rate. The current failure rate is approx 60%.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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27/09/1999
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Anticipated end date
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01/09/2001
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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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214
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Interventions
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1. Exposure to audiotapes
2. Standard care
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Primary outcome measure(s)
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The intervention will be considered effective if it reduced the failure rate by 20-40%. To have an 80% power of detecting such a difference as statistically significant at the 5% two sided level could required 107 children per group (214 in total). This service sees approximately 150 patients per month, in this age group. Assuming 60% agree to take part, then to recruit 214 children will take approximately 3 months. The main outcome measure is the difference in the failure rate between the two groups (intervention and control) failures to attend for appointments will be compared by a Chi squared test. 95% confidence intervals for the differences in failures to attend for appointments between the two groups will also be calculated.
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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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NHS Executive Trent (UK)
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Trial website
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Publications
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Contact name
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Ms
Rosemarie
Khan
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Address
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Community Dental Service
Community Health Sheffield NHS Trust
Fulwood House
Old Fulwood Road
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City/town
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Sheffield
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Zip/Postcode
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S10 3TH
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Country
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United Kingdom
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Tel
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+44 (0)114 272 8802
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Fax
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+44 (0)114 271 6368
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Email
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Sponsor
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NHS R&D Regional Programme Register - 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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Fax
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+44 (0)20 7307 2623
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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.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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08/08/2011
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Date ISRCTN assigned
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23/01/2004
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