The effect of patient education on compliance with drug therapy for rheumatoid arthritis

ISRCTN	ISRCTN68585617
DOI	https://doi.org/10.1186/ISRCTN68585617
Secondary identifying numbers	B0508

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Jackie Hill
Scientific

CPU (Rheumatism Research)
University of Leeds
Chapel Allerton Hospital
Harehills Lane
Leeds
LS7 4SA
United Kingdom

Phone	+44 (0)113 262 3404
Email	j.hill@leeds.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Other
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Rheumatoid arthritis
Intervention	Experimental group received a patient education programme
Intervention type	Other
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 study start date	12/01/1993
Completion date	31/08/1998

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	12/01/1993
Date of final enrolment	31/08/1998

CPU (Rheumatism Research)

Leeds
LS7 4SA
United Kingdom

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Charity

Arthritis Research Campaign (ARC) (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2001		Yes	No