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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Gothenburg, 스웨덴
- Sahlgrenska University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Regular care
The control-group is treated according to "care as usual" with visits to physician every 6th month.
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Disease activity score (DAS28)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of patients with low Disease activity score (DAS28)
기간: 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)
기간: Baseline, week 26 and 50
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Baseline, week 26 and 50
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Health assessment questionnaire (HAQ)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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,
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Lennart Jacobsson, Professor, Göteborg University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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