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ISRCTN
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ISRCTN03226666
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial (RCT) of a Patient Self-Help Information Book in the Management of Irritable Bowel Syndrome (IBS)
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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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RHC11162
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Study hypothesis
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Use of a self-help guidebook will reduce or modify doctor-patient contacts and improve the health status and symptoms of patients with IBS. Patients randomised to the self-help group will gain additional benefits resulting in better symptom control, reduced anxiety and fewer doctor contacts.
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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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Irritable bowel syndrome
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Participants - inclusion criteria
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1. A working diagnosis of IBS as the reason for the consultation
2. At least one other visit with IBS symptoms in the preceding year
3. IBS diagnosed by GP (or hospital if patient has been seen by specialist) but not necessarily fulfilling 'Rome' criteria
4. Able to read and understand English
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Participants - exclusion criteria
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1. Patients under the age of 18
2. Patients with significant learning difficulty or dementia who, in the opinion of the GP, would be unable to practice self-care
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Anticipated start date
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01/06/2000
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Anticipated end date
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31/05/2003
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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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420
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Interventions
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1. Provision of self-help guidebook
2. Provision of self-help guidebook plus invitation to attend one self-help group meeting
3. Treatment as usual, plus guidebook at the end of the study
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Primary outcome measure(s)
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To test the impact of two self-help interventions (a comprehensive self-help guidebook and a self-help group) on primary care consultation rates and global IBS symptom severity in patients with functional bowel disease
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Secondary outcome measure(s)
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To evaluate attendant changes in a range of other health outcomes, including use of
secondary care, self-care, general health and quality of life.
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Sources of funding
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National Health Service (NHS) UK
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Trial website
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Publications
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Contact name
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Dr
Anne
Kennedy
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Address
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National Primary Care Centre
5th Floor
Williamson Building
University of Manchester
Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Email
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akennedy@fs1.cpcr.man.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - 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.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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18/11/2009
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Date ISRCTN assigned
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23/01/2004
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