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ISRCTN
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ISRCTN14652553
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ClinicalTrials.gov identifier
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Public title
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Decision making competence in people with learning disabilities: can accessible information make the difference between consent and informed consent?
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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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N0530118484
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Study hypothesis
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What are the factors that influence the decision-making abilities of people with learning disabilities? How can decision making skills and abilities of people with learning disabilities be enhanced through the way in which we explain information?
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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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Mental and Behavioural Disorders: Learning difficulties
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Participants - inclusion criteria
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15-20 healthy volunteers who are service users of a range of services which provide services for people with learning disabilities, including Centre 404, Elfrida Society, Islington Learning Disabilities Partnership, etc.
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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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01/01/2003
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Anticipated end date
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31/12/2003
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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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20
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Interventions
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1. Hypothetical dental procedure explained to participants using verbal method of explanation
2. Same dental procedure explained using equivalent accessible information form of explanation, interviews
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Primary outcome measure(s)
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Informing an individual in a way that works with their skills and abilities would ensure that individual is given every opportunity to participate in the decisions being made in their lives.
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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 Community Research Consortium (UK)
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Trial website
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Publications
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Contact name
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Ms
Annetta
Bouius
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Address
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Islington Learning Disabilities Partnership
1 Lowther Road
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City/town
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London
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Zip/Postcode
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N7 8SU
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Country
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United Kingdom
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Tel
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+44 (0)20 7527 6620
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Fax
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+44 (0)20 7527 6607
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Email
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Sponsor
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Record provided by the NHS Trusts Clinical Trials 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)207 307 2622
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Fax
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+44 (0)207 307 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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12/09/2003
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Last edited
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26/10/2011
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Date ISRCTN assigned
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12/09/2003
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