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A randomised, controlled study of outcome and cost effectiveness for Rheumatoid Arthritis (RA) patients attending nurse-led rheumatology clinics: a nationwide multi-centre study
ISRCTN ISRCTN29803766
DOI 10.1186/ISRCTN29803766
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised, controlled study of outcome and cost effectiveness for Rheumatoid Arthritis (RA) patients attending nurse-led rheumatology clinics: a nationwide multi-centre study
Scientific title
Acronym N/A
Serial number at source ARC Grant Ref: 17632
Study hypothesis The outcomes from nurse-led clinics will be non-inferior to those obtained by physician led clinics, but at a lower cost.

Please note that as of 07/06/10 this record has been updated to included changes in the number of participants, and sponsor details (Arthritis Research Campaign [ARC] are now known as Arthritis Research UK). Please also note that the end date of this trial has been extended from 30/06/2010 30/06/2011
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Leeds (West) Research Ethics Committee on the 4th January 2007 (REC ref: 06/Q1205/198).
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Rheumatoid arthritis
Participants - inclusion criteria 1. Positive diagnosis of RA as defined by the American Rheumatism Association
2. Aged 18 years or above
3. Ability to complete questionnaires unaided
Participants - exclusion criteria 1. Patients unwilling to be randomised to a Clinical Nurse Specialist (CNS) or Rheumatologist group
2. Patients suffering from unstabilised concomitant disease
3. Patients awaiting surgery
4. Patients who have already received care from the practitioners involved in the study
Anticipated start date 01/09/2007
Anticipated end date 30/06/2011
Status of trial Completed
Patient information material
Target number of participants As of 07/06/10: 164 (at time of registration: 260)
Interventions Patients will be randomly assigned to one of two groups:
1. A Clinical Nurse Specialist group (Experimental Group [EG])
2. A Rheumatologist group (Control Group [CG])

Both the CNS and the Rheumatologist will continue their usual management practice, including making referrals to any members of the multidisciplinary team, changing treatments etc. All interventions undertaken and referrals made by the CNS and the Rheumatologist should be noted on the schedule provided. Any changes to medication and the length of the consultation should also be documented on the schedule.

Total duration for each patient (in both Experimental group and Control group is 1 year - 56 weeks)
Primary outcome measure(s) The 28-item Disease Activity Scale (DAS-28) score, undertaken by an independent assessor at recruitment visit, and weeks 0, 13, 26, 39 and 52.
Secondary outcome measure(s) Secondary measures include both clinical, haematological and questionnaire data:
1. C-Reactive Protein (CRP) or Erythrocyte Sedimentation Rate (ESR)
2. Pain intensity measured on a 10 cm Visual Analogue Scale (VAS)
3. Length of morning stiffness in hours and minutes
4. Fatigue measured on a 10 cm VAS

Questionnaires comprise the following:
5. Health Assessment Questionnaire (HAQ), completed at recruitment visit, week 26 and week 52
6. Hospital Anxiety and Depression Scale (HAD), completed at recruitment visit, week 26 and week 52
7. Leeds Satisfaction Questionnaire (LSQ), completed at recruitment visit, week 26 and week 52
8. The Arthritis Self Efficacy Scale (ASES), completed at recruitment visit, week 26 and week 52
9. Rheumatoid Arthritis Quality of Life questionnaire (RAQoL), completed at recruitment visit, week 26 and week 52
10. EuroQoL (EQ-5D) health outcome instrument, completed at recruitment visit, and weeks 0, 13, 26, 39 and 52
Sources of funding Arthritis Reseach UK (UK) (Grant Ref: 17632)
Trial website
Publications 1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19321512
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21334623
Contact name Dr  Jackie  Hill
  Address Academic and Clinical Unit for Musculoskeletal Nursing (ACUMeN)
Section of Musculoskeletal Disease
Leeds Institute of Molecular Medicine
University of Leeds
2nd Floor, Chapel Allerton Hospital
Chapeltown Road
  City/town Leeds
  Zip/Postcode LS7 4SA
  Country United Kingdom
Sponsor Arthritis Reseach UK (UK)
  Address Copeman House
St Mary's Court
St Mary's Gate
  City/town Chesterfield
  Zip/Postcode S41 7TD
  Country United Kingdom
  Sponsor website: http://www.arthritisresearchuk.org/
Date applied 13/09/2007
Last edited 21/12/2011
Date ISRCTN assigned 21/09/2007
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