A randomised, controlled study of outcome and cost effectiveness for Rheumatoid Arthritis (RA) patients attending nurse-led rheumatology clinics: a nationwide multi-centre study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29803766

Enrollment

164

Registered

2007-09-21

Start date

2007-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis

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 Rheumatolo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026