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
Protocol serial number	535913
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

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

University of Leeds
Rheumatology & Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom

Phone	+44 (0)113 233 4952
Email	p.helliwell@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/1994

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Leeds

Leeds
LS2 9NZ
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	01/04/1999		Yes	No