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ISRCTN
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ISRCTN33534489
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ClinicalTrials.gov identifier
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Public title
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The management of anxiety in Alzheimer's disease - A pilot study of a single-blind randomised controlled trial using an intervention package with a three month follow-up
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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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N0577167824
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Study hypothesis
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Does the management of anxiety in Alzheimer's disease result in a significant reduction in anxiety, improved QoL and an improvement in carer mental health?
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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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Nervous System Diseases: Alzeihmer's disease
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Participants - inclusion criteria
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Participants will be selected from 5 centres within North East London Mental Health Trust.
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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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01/11/2005
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Anticipated end date
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01/08/2006
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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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Not provided at time of registration
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Interventions
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1. Systematic review of evidence.
2. Recruiting participants through day centres, lunch clubs with specialist provision for dementia.
3. Randomisation of participants.
4. Intervention package, which will involve a stepped care plan using physical, drug, social and psychological interventions.
5. Follow-up, which will be done 3 months post intervention.
6. Data-Analysis will be done on an intent to treat basis and will be achieved by using analysis of co-variance.
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Primary outcome measure(s)
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Rating of Anxiety in Dementia (RAID), QoL-AD and the General Health Questionnaire (GHQ-12)
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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 East London Mental Health NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Afifa
Qazi
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Address
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Old Age Psychiatry
Mascalls Park Hospital
Mascalls Lane
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City/town
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Brentwood
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Zip/Postcode
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CM15 5HQ
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Country
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United Kingdom
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Tel
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+44 01277 302736
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Fax
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+44
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Email
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afifaqazi@hotmail.com
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Sponsor
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Record Provided by the NHSTCT Register - 2006 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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29/09/2006
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Last edited
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19/02/2008
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Date ISRCTN assigned
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29/09/2006
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