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ISRCTN
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ISRCTN25574370
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ClinicalTrials.gov identifier
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Public title
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A randomised single blind controlled trial evaluating an evidence-based psychological therapy package for dementia
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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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RDC01638
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Study hypothesis
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The study is a randomised single blind controlled trial evaluating an evidence-based psychological therapy package for people with dementia, both in day care and in residential care. In addition, the study will develop and evaluate a training package which will enable a variety of disciplines to organise and run similar groups.
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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 single blind 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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Nervous system diseases: Dementia
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Participants - inclusion criteria
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220 patients (65 or over) with dementia attending psychiatric day hospitals or dementia day centres, or in residential homes.
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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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01/10/1999
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Anticipated end date
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01/03/2002
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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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220
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Interventions
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1. Psychological therapy
2. Standard care
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Primary outcome measure(s)
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Mini Mental State Examination (MMSE) (Folstein et al., 1975) A brief, well established valid and reliable test of cognitive function. Widely used in the evaluation of drug trials and psychological therapies. The MMSE would enable the results of this study to be compared with the results of other researchers.
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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 London (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17394129
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Contact name
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Dr
Martin
Orrell
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Address
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University College London Medical School
Wolfson Building
Riding House Street
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City/town
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London
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Zip/Postcode
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W1N 8AA
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Country
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United Kingdom
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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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08/12/2008
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Date ISRCTN assigned
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23/01/2004
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