Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/10378705

Publication citations

  1. 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.

Additional files

Editorial Notes