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ISRCTN
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ISRCTN43867447
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ClinicalTrials.gov identifier
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Public title
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Feasibility study to compare self-help interventions of fatigue management in patients with multiple sclerosis: a randomised controlled trial
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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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N0050171956
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Study hypothesis
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Does a self-help leaflet based on cognitive behaviour therapy principles improve patients ability to cope with symptoms of fatigue compared with the current leaflet.
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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 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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Multiple sclerosis (MS)
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Participants - inclusion criteria
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All patients will be identified from the MS Nurse's current caseload and will have identified fatigue as a significant symptom in the last 12 months.
Inclusion Criteria:
1. Patients with Relapsing Remitting Multiple Sclerosis who are usually ambulant
2. Score of between 3-4 on the fatigue questionnaire
3. Over 18 years of age
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Participants - exclusion criteria
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1. Patients who do not wish to be involved in the study
2. Patients receiving anti-fatigue medication (amantadine)
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Anticipated start date
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16/09/2005
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Anticipated end date
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31/05/2006
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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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32 participants
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Interventions
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Feasibility study organised as a pilot randomised controlled trial comparing cognitive behaviour self help leaflet with standard fatigue advice leaflet.
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Primary outcome measure(s)
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Increased ability to cope with fatigue scale and Hospital Anxiety and Depression Scale (HADS).
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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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Bradford Teaching Hospitals NHS Foundation Trust
Bradford Royal Infirmary
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Trial website
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Publications
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Contact name
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Miss
Liz
Watson
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Address
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St lukes Hospital
Little Horton Lane
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City/town
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Bradford
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Zip/Postcode
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BD5 0NA
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Country
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United Kingdom
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Tel
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+44 (0)1274 365249
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Fax
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+44 (0)1274 365797
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Email
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liz.watson@bradfordhospitals.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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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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08/12/2010
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Date ISRCTN assigned
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29/09/2006
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