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 |
| Secondary identifying numbers | ARC 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Diagnostic |
| 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 | 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 study start date | 01/09/2007 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | As of 07/06/10: 164 (at time of registration: 260) |
| 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
- England
- United Kingdom
Study participating centre
Academic and Clinical Unit for Musculoskeletal Nursing (ACUMeN)
Leeds
LS7 4SA
United Kingdom
LS7 4SA
United Kingdom
Sponsor information
Arthritis Reseach UK (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
| Website | http://www.arthritisresearchuk.org/ |
|---|---|
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Reseach UK (UK) (Grant Ref: 17632)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
