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ISRCTN
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ISRCTN92582254
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ClinicalTrials.gov identifier
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Public title
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Rehabilitation of Memory in Neurological Disabilities - Pilot study
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Scientific title
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A comparison of the effectiveness of two types of neuropsychological rehabilitation for memory deficits following brain damage: A single blind randomised controlled trial
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Acronym
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ReMIND - Pilot study
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Serial number at source
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N0192147133
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Study hypothesis
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The aim of this study is to compare the effectiveness of two types of cognitive rehabilitation techniques (ie restitution and compensation) in reducing memory deficits following brain damage.
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Lay summary
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Ethics approval
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Ethical approval obtained from Central Office for Research Ethics Committees, Nottingham Research Ethics Committee 1 (12 May 2004)
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Study design
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Single blind 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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Stroke, Traumatic Brain Injury (TBI), Multiple Sclerosis (MS) / memory deficits
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Participants - inclusion criteria
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Prior to July 2008:
Participants having sustained a brain damage, verified by hospital or GP records, should have a memory deficit, defined as overall profile score of 1 (poor memory) or 0 (impaired) on the Rivermead Behavioural memory Test (RBMT), over 18 years of age, living in or around Nottingham (within 50 miles radius), having at least one identified individual who will supervise homework assignments, they give informed consent, they are not blind or deaf, should speak English, should have been diagnosed at least one month prior to recruitment to the study, should be more than one month post injury and or diagnosis, no previous diagnosis of brain damage or other severe disability.
Modified July 2008:
Participants with a stroke, TBI, or MS, verified by hospital or GP records, should have a memory deficit, defined as overall profile score of 2 (average memory) to 0 (impaired) on the Rivermead Behavioural memory Test-extended version (RBMTE), over 18 years of age, living in or around Nottingham or Derby (within 50 miles radius), having at least one identified individual who will supervise homework assignments, they give informed consent, should speak English, and should be more than one month post injury and or diagnosis.
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Participants - exclusion criteria
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Added July 2008:
Those who are blind or deaf, have previous diagnosis of brain damage or dementia, have severe activity limitations which would restrict them from taking part in assessments or intervention, current psychiatric/mental health problems, and language problems (defined as a score of less than 15 on the Sheffield Screening Test for Acquired Language Disorders).
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Anticipated start date
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24/05/2004
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Anticipated end date
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31/01/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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At least 60 patients in each group (restitution group, compensation group, attention placebo group) = 180.
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Interventions
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1. Restitution group
2. Compensation group
3. Attention placebo group
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Primary outcome measure(s)
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Prior to July 2008:
To assess memory functions, disability, psychological adjustment.
Modified July 2008:
To assess everyday memory functions, based on the Everyday Memory Questionnaire.
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Secondary outcome measure(s)
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Added July 2008:
Objective measures of memory (RBMTE, Doors & People, Memory Aids Questionnaire), mood (GHQ12, Wimbledon Self Report Scale), psychological adjustment (Mental Adjustment to Brain Damage), and extended activities of daily living (Nottingham EADL).
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Sources of funding
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1. Queen's Medical Centre University Hospital NHS Trust (UK) NHS R&D Support Funding
Added July 2008:
2. Stroke Association (UK) (AHP Research Bursary)
3. Remedi (UK)
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Trial website
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Publications
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Contact name
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Prof
N
Lincoln
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Address
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University of Nottingham
University Hospital
Institute of work, Health and Organisations
8 William Lee buildings, Science and Technology Park
University Boulevard
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City/town
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Nottingham
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Zip/Postcode
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NG7 2RQ
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Country
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United Kingdom
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Tel
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+44 (0)115 87523846
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Fax
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+44 (0)115 8466625
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Email
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nadina.lincoln@nottingham.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 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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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.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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11/07/2008
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Date ISRCTN assigned
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30/09/2005
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