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ISRCTN
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ISRCTN68585617
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ClinicalTrials.gov identifier
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Public title
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The effect of patient education on compliance with drug therapy for rheumatoid arthritis
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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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B0508
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Study hypothesis
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Treatment of rheumatoid arthritis (RA) by disease-modifying drugs in which dosage is not symptom driven, is subject to substantial variation in compliance. Our previous work, using a novel pharmacological 'gold standard' for the measurement of compliance in which D-penicillamine was labelled with a homeopathic dose of phenobarbitone, showed that 42% of patients failed to follow instructions of dosage. It is proposed to use the same objective technique, validated clinical measures and a proven knowledge questionnaire, to investigate the effect on compliance of two different levels of patient education amongst RA patients.
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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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Rheumatoid arthritis
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Participants - inclusion criteria
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1. All patients deemed by the consultant rheumatologist to require dPenicillamine (DPA) as their disease modifying anti-rheumatic drug (DMARD)
2. Over 18 years of age
3. Plasma Viscosity (PV) ≤1.75
4. Cysteine rich protein (CRP) ≤10
5. Articular index 15 or less than
6. Morning stiffness ≤45 min
7. Pain level moderate/severe
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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12/01/1993
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Anticipated end date
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31/08/1998
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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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Not provided at time of registration
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Interventions
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Experimental group received a patient education programme
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Primary outcome measure(s)
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It is anticipated that effective education will enhance compliance leading to better drug utilisation and improved patient outcome.
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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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Arthritis Research Campaign (ARC) (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/11502614
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Contact name
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Ms
Jackie
Hill
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Address
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CPU (Rheumatism Research)
University of Leeds
Chapel Allerton Hospital
Harehills Lane
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City/town
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Leeds
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Zip/Postcode
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LS7 4SA
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Country
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United Kingdom
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Tel
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+44 (0)113 262 3404
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Email
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j.hill@leeds.ac.uk
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Sponsor
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Arthritis Research Campaign (ARC) (UK)
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Address
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Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
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City/town
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Derbyshire
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Zip/Postcode
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S41 7TD
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Country
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United Kingdom
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Email
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info@arc.org.uk
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Sponsor website:
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http://www.arc.org.uk
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Date applied
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30/07/2002
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Last edited
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09/09/2009
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Date ISRCTN assigned
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30/07/2002
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