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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Gothenburg、スウェーデン
- Sahlgrenska University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：Regular care
The control-group is treated according to "care as usual" with visits to physician every 6th month.
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Disease activity score (DAS28)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of patients with low Disease activity score (DAS28)
時間枠：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)
時間枠：Baseline, week 26 and 50
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Baseline, week 26 and 50
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Health assessment questionnaire (HAQ)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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,
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Lennart Jacobsson, Professor、Göteborg University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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