Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Controlled Study Evaluating the Efficacy of Person-centered, Tight Control Nurse-led Clinic of Patients With Established Rheumatoid Arthritis and Moderate to High Disease Activity Compared to Patients Receiving Regular Care
Verified date | May 2017 |
Source | Vastra Gotaland Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 8, 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region | Göteborg University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Disease activity score (DAS28) | The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate | Baseline, week 26 and 50 | |
Secondary | Proportion of patients with low Disease activity score (DAS28) | Baseline, week 26 and 50 | ||
Secondary | Proportion of patients with remisson according to Disease activity score (DAS28) | Baseline, week 26 and 50 | ||
Secondary | Health assessment questionnaire (HAQ) | Measures functional status | Baseline, week 26 and 50 | |
Secondary | EuroQol (EQ-5D) | Measures health status, allowing computation of cost-effectiveness | Baseline, week 26 and 50 | |
Secondary | Visual analogue scale for pain (VAS-pain) | Measures the patient's pain | Baseline, week 26 and 50 | |
Secondary | Visual analogue scale fatigue (VAS-Fatigue) | Measures the patient's fatigue. | Baseline, week 26 and 50 | |
Secondary | Visual analogue scale general health (VAS-general health) | Measures the patient's general health. | Baseline, week 26 and 50 | |
Secondary | Effective Consumer Survey 17 (EC17) | Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills | Baseline, week 26 and 50 | |
Secondary | Rheumatoid Arthritis Impact of Disease (RAID) score, | A patient-derived composite measure of the impact of the disease | Baseline, week 26 and 50 | |
Secondary | The beliefs about medicines questionnaire (BMQ) | Assessing patients' perceptions and expectation about medicines | Baseline,week 26 and 50 | |
Secondary | Numerical Rating Scale (NRS) about satisfaction with care | Measures satisfaction with rheumatology care | Baseline, week 26 and 50 |
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