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ISRCTN
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ISRCTN98029969
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ClinicalTrials.gov identifier
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Public title
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Social-environmental, psychological and physical approaches to stroke rehabilitation
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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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HTA 93/03/11
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Study hypothesis
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This COllaborative STroke Audit and Research (COSTAR) group study will evaluate "social", "psychological" or "physical" approaches to rehabilitation of stroke patients in the community, aiming to help families adjust to life after a stroke and reduce long term distress. About 400 patients will be recruited to a randomised controlled trial in Newcastle to receive one, two or none of the interventions in a factorial design allowing the three approaches and the interactions between them to be assessed. This study will be linked with trials of cognitive/behavioural therapy, community occupational therapy and "leisure rehabilitation" being undertaken in Nottingham and with other controlled trials of similar services being planned at other COSTAR centres, in an "epi-analysis" (pre-planned collaboration using standard clinical measures). This large collaboration will provide reliable information on the cost-effectiveness of different forms of community care for stroke patients and their families.
Please note that, as of 25 January 2008, the anticipated end date of this ISRCTN record was updated from 29 February 2000 to 30 November 2001.
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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 with a factorial design
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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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Stroke patients
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Participants - inclusion criteria
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Patients having recently suffered a stroke
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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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01/12/1995
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Anticipated end date
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30/11/2001
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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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400
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Interventions
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1. Social rehabilitation
2. Psychological rehabilitation
3. Physical rehabilitation
4. Standard care
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Primary outcome measure(s)
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Not provided at time of registration.
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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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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11237160
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Contact name
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Prof
David
Barer
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Address
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Department of Medicine (Geriatric Medicine)
University of Newcastle upon Tyne
Queen Elizabeth Hospital
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE9 6SX
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Country
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United Kingdom
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Tel
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+44 (0)191 445 2850
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Fax
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+44 (0)191 403 2842
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Email
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D.H.Barer@NCL.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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30/10/2009
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Date ISRCTN assigned
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25/04/2003
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