Condition category
Musculoskeletal Diseases
Date applied
30/07/2002
Date assigned
30/07/2002
Last edited
09/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.arc.org.uk

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

Results - basic reporting

Publication summary

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11502614

Publication citations

  1. 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.

Additional files

Editorial Notes