Development and evaluation of an education programme in rheumatoid arthritis: impact on compliance, function, disease progression and quality of life
| ISRCTN | ISRCTN37977053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37977053 |
| Secondary identifying numbers | 535913 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 22/02/2008
- 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
Dr Philip Helliwell
Scientific
Scientific
University of Leeds
Rheumatology & Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom
| Phone | +44 (0)113 233 4952 |
|---|---|
| p.helliwell@leeds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Although patient education is assuming an increasingly important role in patient management in many medical disciplines, evaluation of the medium term impact of patient education has not been carried out in rheumatological practice. We wish to know whether a patient education programme will improve compliance with drug, exercise and attendance regimes and the impact of education on disease progression, function and quality of life. We plan a randomised controlled trial of patient education in rheumatoid arthritis based on an ambulant population. We will evaluate the educational benefits of the programme over a four week period and make further outcome assessments for the 12 months following entry into the trial. We hope to show increased compliance with drug regimes and drug monitoring, retention of knowledge and orthodox attitudes to disease management, a reduction in periods of inpatient treatment and unscheduled outpatient attendance. The benefits would accrue primarily to the patients in terms of quality of life and disease progression but would contribute to the cost efficient organisation of the rheumatology department (including number of patient episodes) and in pharmacy costs (currently due, in part, to poor drug compliance and wastage). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal diseases: Arthritis (rheumatoid) |
| Intervention | 1. Patient education programme 2. Standard care |
| Intervention type | Other |
| Primary outcome measure | Compliance with drug, exercise and attendance regimes and disease progression, function and quality of life. The main outcome variables were the modified Larsen radiological score for the hands and the 36-item short form health survey (SF-36) quality of life questionnaire. |
| Secondary outcome measures | 1. Health Assessment Questionnaire (HAQ) 2. Ritchie Articular Index (RAI) 3. Patient Knowledge Questionnaire (PKQ) 4. Compliance Questionnaire (CQ) 5. Plasma viscosity (PV) 6. Pharmaceutical changes and consulting behaviour |
| Overall study start date | 01/01/1992 |
| Completion date | 31/12/1994 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 77 |
| Key inclusion criteria | Patients with rheumatoid arthritis. |
| Key exclusion criteria | 1. Unable to speak or read english 2. Previous education programme |
| Date of first enrolment | 01/01/1992 |
| Date of final enrolment | 31/12/1994 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9NZ
United Kingdom
LS2 9NZ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/04/1999 | Yes | No |
