Outpatient Follow-up on Demand in Rheumatoid Arthritis
Patient-controlled Outpatient Follow-up on Demand for Patients With Rheumatoid Arthritis: a Two-year Randomized Trial
연구 개요
상세 설명
A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. At baseline, patients were randomized electronically with stratification according to biologic and non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at baseline, year 1 and 2, including assessment of disease activity (DAS-28), blood tests, bone erosions on plain radiographs of hands and feet, and patient reported outcome measures.
The objective of the study was to compare an outpatient system for Danish RA patients based on patient self-controlled outpatient follow up on demand, Open Outpatient Clinic Programme with traditional scheduled routine follow-up regarding patient satisfaction and effect on traditional disease markers.
The Danish National Patient Registry (DANBIO) was used to identify eligible patients with RA. At pre-planned routine visits with the rheumatologist, identified patients were screened according to inclusion and exclusion criteria.
The intervention group had no scheduled appointments at the outpatient clinic, but they could book acute appointments with their contact rheumatologist within 5 days or less whenever they deemed it necessary. They also had access to nurse-led consultations without pre-booked appointments and to a nurse-led telephone helpline
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Copenhagen
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Hellerup, Copenhagen, 덴마크, 2900
- University Hospital Gentofte
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
RA. Disease duration of at least 1 year.
Exclusion Criteria:
Patients treated with monthly intravenous biological medicine
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Open outpatient clinic programme (OOCP)
OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist, and had access to nurse-led consultations and telephone helpline.
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간섭 없음: Traditional scheduled routine follow up (TSRF)
Appointments for the TSRF group were scheduled according to routine procedures.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual analogue Scale (VAS) Patient satisfaction
기간: 2 years
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Patient reported outcome which assess overall how satisfied the patient is regarding the management of their rheumatoid arthritis in the hospital setting.
Patient satisfaction is scored on a visual analogue scale (VAS).
Minimum score is 0 (worst), and maximum score 100 (best).
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disease activity score in 28 joints (DAS28)
기간: 2 years
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DAS28 is a measure of disease activity in rheumatoid arthritis.
To calculate the DAS28 we counted the number of swollen joints and tender joints (out of the 28), measured C reactive protein (CRP) and assessed the patients 'global assessment of health' (indicated on a visual analogue scale from 0 (best) to 100 (worst)
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2 years
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Radiographic progression
기간: 2 year
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Radiographs of hands and feet were compared between baseline and follow-up, regarding development of structural changes, including bone erosions.
A musculoskeletal radiologist evaluated whether erosive development or progression was present.
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2 year
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공동 작업자 및 조사자
수사관
- 연구 의자: Annette Hansen, University Hospital Gentofte
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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