Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, Person-centered care, Tight control
Brief summary
Purpose: To compare a nurse-led clinic including person-centered care and tight control with care as usual in patients with rheumatoid arthritis (RA) and moderate/ high disease activity. Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high Disease Activity Score of 28 joints (DAS28 \> 3.8) and disease duration \> 2 yrs in a 6-month randomized controlled study with a 6 month open follow-up. Intervention group (N=60): Nurse-led visits every 6th week, with structured person-centered care and evaluation of disease activity. If disease remission is not reached, pharmacological treatment including both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and biologics) is modified according to a predefined algorithm. The control group (N=60) is treated according to care as usual with visits to physician every 6th month. Outcome measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue, sleep and satisfaction.
Interventions
OTHERNurse-led clinic
Sponsors
Göteborg University
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ≥18 and \<80 years of age * Signed and dated informed consent form before the start of any specific protocol procedures * Fulfill the 1987 ACR criteria or the 2010 ACR/EULAR criteria for RA with disease duration of \>2 years * Moderate to high disease activity (DAS28 \>3.8) * ≥2 swollen joints
Exclusion criteria
* Diagnosis of any other inflammatory arthritis * History of chronic infection, recent serious or life-threatening infection within 6 months * Concurrent malignancy, a history of malignancy or current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease activity score (DAS28) | Baseline, week 26 and 50 | The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale for pain (VAS-pain) | Baseline, week 26 and 50 | Measures the patient's pain |
| Proportion of patients with low Disease activity score (DAS28) | Baseline, week 26 and 50 | — |
| Proportion of patients with remisson according to Disease activity score (DAS28) | Baseline, week 26 and 50 | — |
| Health assessment questionnaire (HAQ) | Baseline, week 26 and 50 | Measures functional status |
| Visual analogue scale fatigue (VAS-Fatigue) | Baseline, week 26 and 50 | Measures the patient's fatigue. |
| EuroQol (EQ-5D) | Baseline, week 26 and 50 | Measures health status, allowing computation of cost-effectiveness |
| Effective Consumer Survey 17 (EC17) | Baseline, week 26 and 50 | Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills |
| Rheumatoid Arthritis Impact of Disease (RAID) score, | Baseline, week 26 and 50 | A patient-derived composite measure of the impact of the disease |
| The beliefs about medicines questionnaire (BMQ) | Baseline,week 26 and 50 | Assessing patients' perceptions and expectation about medicines |
| Numerical Rating Scale (NRS) about satisfaction with care | Baseline, week 26 and 50 | Measures satisfaction with rheumatology care |
| Visual analogue scale general health (VAS-general health) | Baseline, week 26 and 50 | Measures the patient's general health. |
Countries
Sweden
Outcome results
None listed