Contact information
Type
Scientific
Primary contact
Ms Jackie Hill
ORCID ID
Contact details
CPU (Rheumatism Research)
University of Leeds
Chapel Allerton Hospital
Harehills Lane
Leeds
LS7 4SA
United Kingdom
+44 (0)113 262 3404
j.hill@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
B0508
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
Experimental group received a patient education programme
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
It is anticipated that effective education will enhance compliance leading to better drug utilisation and improved patient outcome.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
12/01/1993
Overall trial end date
31/08/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
12/01/1993
Recruitment end date
31/08/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CPU (Rheumatism Research)
Leeds
LS7 4SA
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11502614
Publication citations
-
Results
Hill J, Bird H, Johnson S, Effect of patient education on adherence to drug treatment for rheumatoid arthritis: a randomised controlled trial., Ann. Rheum. Dis., 2001, 60, 9, 869-875.