Testing an Increased Visit Interval scHeme UsIng Web-based Self-evaluation in Patients With Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Disease flares
研究概览
简要总结
In the THUIS study, JIA patients in clinical remission will skip one 3-monthly hospital control visit and instead monitor their disease activity at home. Outcomes at 6 months will be compared to those from a historical cohort.
详细描述
Background:
Children with juvenile idiopathic arthritis (JIA) commonly visit their pediatric rheumatologist every 3 months. This costs time and money for the patient, their parents or guardian, the hospital and other stakeholders. Therefore, the THUIS study aims to demonstrate that JIA patients in clinical remission can safely increase their visit interval by home-monitoring disease activity using the EuroQol five-dimensional youth questionnaire with five levels (EQ-5D-Y-5L) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR).
Methods:
JIA patients in remission from the Wilhelmina Children's Hospital in Utrecht, the Netherlands, will skip one 3-monthly control visit and instead complete an online EQ-5D-Y-5L and JAMAR questionnaire at home. The home-monitoring results will be evaluated by a research nurse in consultation with the treating pediatric rheumatologist in order to determine if the patient can safely remain at home or has to be planned in for a short-term control visit at the hospital. Primary and secondary outcomes after 6 months will be compared with a historical cohort of matched JIA patients in order to prove non-inferiority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •JIA diagnosis of ≥1 year, all subtypes can participate
- •Clinical remission, defined as a cJADAS of ≤3
排除标准
- •Insufficient control of the Dutch language
- •Not able or willing to use e-mail
结局指标
主要结局
Disease flares
时间窗: 5-7 months after inclusion.
The number of disease flares 6 months after baseline visit. A disease flare is defined as a cJADAS score of \>3.
次要结局
- Disease flares at rescheduled visits(Through study completion, an average of 6 months)
- Patient satisfaction(5-7 months after inclusion.)
- Rescheduled visits(Through study completion, an average of 6 months)
- Adverse events(Through study completion, an average of 6 months)
- Reminders(Through study completion, an average of 6 months)
- Failure(Through study completion, an average of 6 months)
研究者
Joeri van Straalen
Epidemiologist, coordinating researcher
UMC Utrecht