Condition category
Musculoskeletal Diseases
Date applied
13/09/2007
Date assigned
21/09/2007
Last edited
21/12/2011
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 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

http://www.arthritisresearchuk.org/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes