GotNet Study, The Gothenburg Nurse-led Tight Control Study
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
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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Gothenburg, Sverige
- Sahlgrenska University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Regular care
The control-group is treated according to "care as usual" with visits to physician every 6th month.
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Experimentell: Nurse-led clinic
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Disease activity score (DAS28)
Tidsram: Baseline, week 26 and 50
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The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate
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Baseline, week 26 and 50
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of patients with low Disease activity score (DAS28)
Tidsram: Baseline, week 26 and 50
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Baseline, week 26 and 50
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Proportion of patients with remisson according to Disease activity score (DAS28)
Tidsram: Baseline, week 26 and 50
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Baseline, week 26 and 50
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Health assessment questionnaire (HAQ)
Tidsram: Baseline, week 26 and 50
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Measures functional status
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Baseline, week 26 and 50
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EuroQol (EQ-5D)
Tidsram: Baseline, week 26 and 50
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Measures health status, allowing computation of cost-effectiveness
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Baseline, week 26 and 50
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Visual analogue scale for pain (VAS-pain)
Tidsram: Baseline, week 26 and 50
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Measures the patient's pain
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Baseline, week 26 and 50
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Visual analogue scale fatigue (VAS-Fatigue)
Tidsram: Baseline, week 26 and 50
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Measures the patient's fatigue.
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Baseline, week 26 and 50
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Visual analogue scale general health (VAS-general health)
Tidsram: Baseline, week 26 and 50
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Measures the patient's general health.
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Baseline, week 26 and 50
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Effective Consumer Survey 17 (EC17)
Tidsram: Baseline, week 26 and 50
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Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills
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Baseline, week 26 and 50
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Rheumatoid Arthritis Impact of Disease (RAID) score,
Tidsram: Baseline, week 26 and 50
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A patient-derived composite measure of the impact of the disease
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Baseline, week 26 and 50
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The beliefs about medicines questionnaire (BMQ)
Tidsram: Baseline,week 26 and 50
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Assessing patients' perceptions and expectation about medicines
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Baseline,week 26 and 50
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Numerical Rating Scale (NRS) about satisfaction with care
Tidsram: Baseline, week 26 and 50
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Measures satisfaction with rheumatology care
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Baseline, week 26 and 50
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Lennart Jacobsson, Professor, Göteborg University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GotNet 2014 SU
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