Effectiveness and Cost-effectiveness of Monitoring Spondyloarthritis With the Integrated eHealth System SpA-Net: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Number of scheduled and unscheduled outpatient visits to the rheumatology department.
研究概览
简要总结
Randomized controlled trial to assess the effectiveness and cost-effectiveness of an intervention combining patient initiated care and telemonitoring through the online eHealth platform SpA-Net versus standard care for patients with spondyloarthritis.
详细描述
Multicenter randomized controlled trial to investigate the effectiveness and cost-effectiveness of telemonitoring through SpA-Net, in combination with patient initiated care, versus standard care. Participants will be recruited at the outpatient clinics of participating centers, and will be randomised (after informed consent) into either the telemonitoring or standard care group. Patients in both arms will use SpA-Net and will be followed up for 1 year. Concomitantly a trial-based cost-utility analysis will be performed.
Randomisation (1:1; intervention versus standard care) is done using the minimisation method, stratifying for medical centre, subtype of SpA (axial, peripheral or combined) and treatment (biological use versus no biological use). Due to the nature of the intervention neither patients nor clinicians can be blinded to the allocation.
A sample size of 80 patients per group is necessary to detect the primary outcome with a power of 0.80 and alpha of 0.05. Assuming a 20% drop-out during follow-up, 100 patients per group will be included. This sample size also suffices to show non-inferiority for all secondary objectives with a power of 0.80 and a one-sided alpha of 0.025.
Study endpoints
A. The primary endpoint is defined as at least 25% reduction in the number of rheumatology department outpatient visits in the intervention group compared to the standard care group, within a 1-year follow-up period. Due to the COVID-19 pandemic these may also take place through telephone or video calls, replacing physical visits.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient (18+ years)
- •Diagnosis of SpA according to treating physician
- •At least 2 years of disease duration, to be familiar with signs, symptoms, and medication
- •Stable disease, defined as being in a patient acceptable symptom state according to patient AND treating physician AND no treatment change expected in the next few months
- •Access to a computer, tablet and/or smartphone for the entire duration of the study
排除标准
- •Insufficient mastery of Dutch language
- •Incompetent to act for oneself
- •Limited life expectancy
- •Ongoing (or planned) pregnancy during the study period
- •Patients participating in other research project(s)
结局指标
主要结局
Number of scheduled and unscheduled outpatient visits to the rheumatology department.
时间窗: 1 year
Comparison of total number of outpatient visits in a 1-year period between intervention and control group.
次要结局
- Ankylosing Spondylitis Disease Activity Score (ASDAS)(1 year)
- Global well-being patient(1 year)
- Psoriasis severity: Nail involvement(1 year)
- Disease activity according to physician(1 year)
- Psoriasis severity: Body Surface Area (BSA)(1 year)
- Patient reported pain(1 year)
- Tender Joint Count 66 / Swollen Joint Count 68(1 year)
- Presence of dactylitis and/or enthesitis(1 year)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(1 year)
- C-Reactive Protein (CRP)(1 year)
- Assessment of SpondyloArthritis international Society health index (ASAS HI)(1 year)
- EuroQol with 5 dimensions and 5 point Likert scale (EQ-5D-5L)(1 year)
- 36-item Short Form Health Survey (SF-36)(1 year)