Contact information
Type
Scientific
Primary contact
Dr Philip Helliwell
ORCID ID
Contact details
University of Leeds
Rheumatology & Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom
+44 (0)113 233 4952
p.helliwell@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
535913
Study information
Scientific title
Acronym
Study hypothesis
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
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
Not Specified
Patient information sheet
Condition
Musculoskeletal diseases: Arthritis (rheumatoid)
Intervention
1. Patient education programme
2. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
01/01/1992
Overall trial end date
31/12/1994
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with rheumatoid arthritis.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
77
Participant exclusion criteria
1. Unable to speak or read english
2. Previous education programme
Recruitment start date
01/01/1992
Recruitment end date
31/12/1994
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9NZ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/10378705
Publication citations
-
Results
Helliwell PS, O'Hara M, Holdsworth J, Hesselden A, King T, Evans P, A 12-month randomized controlled trial of patient education on radiographic changes and quality of life in early rheumatoid arthritis., Rheumatology (Oxford), 1999, 38, 4, 303-308.