The effect of patient education on compliance with drug therapy for rheumatoid arthritis
| ISRCTN | ISRCTN68585617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68585617 |
| Protocol serial number | B0508 |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Funder | Arthritis Research Campaign (ARC) (UK) |
- Submission date
- 30/07/2002
- Registration date
- 30/07/2002
- Last edited
- 09/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Jackie Hill
Scientific
Scientific
CPU (Rheumatism Research)
University of Leeds
Chapel Allerton Hospital
Harehills Lane
Leeds
LS7 4SA
United Kingdom
| Phone | +44 (0)113 262 3404 |
|---|---|
| j.hill@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
It is anticipated that effective education will enhance compliance leading to better drug utilisation and improved patient outcome. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CPU (Rheumatism Research)
Leeds
LS7 4SA
United Kingdom
LS7 4SA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2001 | Yes | No |
