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ISRCTN
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ISRCTN01712819
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ClinicalTrials.gov identifier
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Public title
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Improving the needs of people with dementia in care homes
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Scientific title
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A single blind randomised controlled study to identify and address the needs of older people with dementia in residential care
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Acronym
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N/A
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Serial number at source
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061627
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Study hypothesis
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1. To compare the met and unmet needs of dementia sufferers in residential care from a range of areas
2. To investigate the relationship between costs of care, quality of life and met and unmet needs
3. To determine and cost appropriate interventions to meet unmet needs and provide systematic feedback on the needs and suggested interventions to the care staff for a 50% sample
4. To follow up all dementia sufferers six months later and examine whether systematic feedback of needs resulted in interventions being carried out, the actual cost of the individual interventions and the costs of other outcomes (e.g. hospital admission)
As of 10/03/2009 this record was updated to include an amended end date; the initial end date at the time of registration was 31/05/2005. All other changes can be found under the relevant field with the above update date.
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Lay summary
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Ethics approval
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Added 10/03/2009: London MREC gave approval on the 1st November 2000 (ref: MREC/00/2/77)
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Study design
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Single-blind cluster 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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Dementia
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Participants - inclusion criteria
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Inclusion of residents into the study was completed using the following procedure:
1. All residents over 60 years old, either sex, who showed signs of dementia
2. Had resided permanently in the home for the past month
3. Had intentions of staying
4. Were identified by the home manager and the researcher using the National Institute of Social Workers (NISW) Noticeable Problems checklist (Levin, Sinclair, & Gorbach, 1989)
The list of residents with probable and possible dementia was then further screened by the researcher to ensure they had a diagnosis of dementia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]; APA, 1994) using care home notes and clinical assessments. Those with a DSM-IV diagnosis of dementia were entered into the randomisation procedure.
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Participants - exclusion criteria
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Does not meet with inclusion criteria
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Anticipated start date
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01/05/2000
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Anticipated end date
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31/07/2004
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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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238
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Interventions
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Single-blind cluster randomised controlled trial involving 238 people with dementia living in residential care. 50% of the residential care homes (12 of 24) received feedback on needs of residents and one hour per week over 20 weeks liaison by a research nurse or clinical psychologist.
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Primary outcome measure(s)
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1. Camberwell Assessment of Need for the Elderly
2. Quality of Life in Dementia (QoL-AD)
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Secondary outcome measure(s)
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Added 10/03/2009:
Quality of life at four months.
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 061627)
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Trial website
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Publications
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2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16323258
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Contact name
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Prof
Martin
Orrell
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Address
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University College London
Wolfson Building
Mental Health Sciences
48 Riding House St
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City/town
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London
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Zip/Postcode
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W1W 7EY
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Country
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United Kingdom
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Tel
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+44 (0)20 7679 9452
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Fax
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+44 (0)20 7679 9426
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Email
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m.orrell@ucl.ac.uk
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Sponsor
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University College London (UK)
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Address
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Mental Health Services
Wolfson Building
48 Riding House Street
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City/town
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London
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Zip/Postcode
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W1W 7EY
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Country
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United Kingdom
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Sponsor website:
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http://www.thecane.co.uk
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Date applied
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14/10/2005
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Last edited
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10/03/2009
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Date ISRCTN assigned
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14/10/2005
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