跳至主要内容
临床试验/NCT04476875
NCT04476875已完成不适用

Patient-controlled Outpatient Follow-up on Demand for Patients With Rheumatoid Arthritis: a Two-year Randomized Trial

University Hospital, Gentofte, Copenhagen2 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
282
试验地点
2
主要终点
Visual analogue Scale (VAS) Patient satisfaction

研究概览

简要总结

A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. 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 and reporting of outcomes measures on a touch screen at the clinic.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • RA. Disease duration of at least 1 year.

排除标准

  • Patients treated with monthly intravenous biological medicine

结局指标

主要结局

Visual analogue Scale (VAS) Patient satisfaction

时间窗: 2 years

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).

次要结局

  • Disease activity score in 28 joints (DAS28)(2 years)
  • Radiographic progression(2 year)

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

René Panduro Poggenborg

Principal Investigator

University Hospital, Gentofte, Copenhagen

研究点 (2)

Loading locations...

相似试验