| Source of record | UK Trials |
| ISRCTN | ISRCTN68585617 |
| Date ISRCTN assigned | 30/07/2002 |
| Local reference number(s) | B0508 |
| Public title | The effect of patient education on compliance with drug therapy for rheumatoid arthritis |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Rheumatoid arthritis |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 12/01/1993 |
| Anticipated end date | 31/08/1998 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Experimental group received a patient education programme |
| Primary outcome measure(s) | It is anticipated that effective education will enhance compliance leading to better drug utilisation and improved patient outcome. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Arthritis Research Campaign |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
United Kingdom
S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Ms Jackie Hill |
| Contact details | CPU (Rheumatism Research)
University of Leeds
Chapel Allerton Hospital
Harehills Lane
Leeds
United Kingdom
LS7 4SA |
| Contact telephone | +44 (0)113 262 3404 |
| Contact email | j.hill@leeds.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN68585617 |
| Date last extracted from ISRCTN register | 17/04/2008 |
