Contact information
Type
Scientific
Primary contact
Dr Jackie Hill
ORCID ID
Contact details
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
Leeds
LS7 4SA
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ARC Grant Ref: 17632
Study information
Scientific title
Acronym
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
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)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/09/2007
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
As of 07/06/10: 164 (at time of registration: 260)
Participant 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
Recruitment start date
01/09/2007
Recruitment end date
30/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic and Clinical Unit for Musculoskeletal Nursing (ACUMeN)
Leeds
LS7 4SA
United Kingdom
Sponsor information
Organisation
Arthritis Reseach UK (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Reseach UK (UK) (Grant Ref: 17632)
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
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19321512
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21334623
Publication citations
-
Results
Hill J, Lewis M, Bird H, Do OA patients gain additional benefit from care from a clinical nurse specialist?--a randomized clinical trial., Rheumatology (Oxford), 2009, 48, 6, 658-664, doi: 10.1093/rheumatology/kep049.
-
Results
Ndosi M, Lewis M, Hale C, Quinn H, Ryan S, Emery P, Bird H, Hill J, A randomised, controlled study of outcome and cost effectiveness for RA patients attending nurse-led rheumatology clinics: study protocol of an ongoing nationwide multi-centre study., Int J Nurs Stud, 2011, 48, 8, 995-1001, doi: 10.1016/j.ijnurstu.2011.01.010.