GotNet Study, The Gothenburg Nurse-led Tight Control Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Nurse-led clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Regular care<br>The control-group is treated according to care as usual with visits to physician every 6th month. | |
| Experimental: Nurse-led clinic<br>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. | Other: Nurse-led clinic<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Measures functional status | Baseline, week 26 and 50 | 
| EuroQol (EQ-5D) | Measures health status, allowing computation of cost-effectiveness | Baseline, week 26 and 50 | 
| Visual analogue scale for pain (VAS-pain) | Measures the patient's pain | Baseline, week 26 and 50 | 
| Visual analogue scale fatigue (VAS-Fatigue) | Measures the patient's fatigue. | Baseline, week 26 and 50 | 
| Visual analogue scale general health (VAS-general health) | Measures the patient's general health. | Baseline, week 26 and 50 | 
| Effective Consumer Survey 17 (EC17) | Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills | Baseline, week 26 and 50 | 
| Rheumatoid Arthritis Impact of Disease (RAID) score, | A patient-derived composite measure of the impact of the disease | Baseline, week 26 and 50 | 
| The beliefs about medicines questionnaire (BMQ) | Assessing patients' perceptions and expectation about medicines | Baseline,week 26 and 50 | 
| Numerical Rating Scale (NRS) about satisfaction with care | Measures satisfaction with rheumatology care | Baseline, week 26 and 50 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Person-centered care, Tight control