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	https://doi.org/10.1186/ISRCTN29803766
Protocol serial number	ARC Grant Ref: 17632
Sponsor	Arthritis Reseach UK (UK)
Funder	Arthritis Reseach UK (UK) (Grant Ref: 17632)

Submission date: 13/09/2007
Registration date: 21/09/2007
Last edited: 21/12/2011

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 Jackie Hill
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the Leeds (West) Research Ethics Committee on the 4th January 2007 (REC ref: 06/Q1205/198).
Health condition(s) or problem(s) studied	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
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.
Key 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
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	164
Key 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
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	30/06/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Academic and Clinical Unit for Musculoskeletal Nursing (ACUMeN)

Leeds
LS7 4SA
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	01/06/2009		Yes	No
Results article	results	01/08/2011		Yes	No