Evaluating the Impact of an Initial Standardized Global Review in Patients With Early Axial Spondyloarthritis: a Multicenter Randomized Cluster-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 21
- 主要终点
- The change in patient knowledge of the disease.
研究概览
简要总结
This study will be a pragmatic, cluster-randomized, controlled study with two parallel arms ( 'intervention' and 'usual care' (UC) arms) of one year duration.
The study will be open-label, but centers randomized in the UC arm will not be aware of the intervention performed in the 'intervention' centers.
The primary objective of this study will be to determine whether participation in a standardized global review (that includes assessment of disease domains and education ) as soon as possible after diagnosis of axial spondyloarthritis has a beneficial impact on patient knowledge of the disease at 12 months. The primary endpoint will be the change in the SPAKE (SPondyloArthritis Knowledge Questionnaire) questionnaire between M0 and M12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Adults (but age <80years) with a diagnosis of axial spondyloarthritis determined by the treating rheumatologist within the 12 months preceding the baseline visit, who have completed the informed consent and have the ability to complete all study activities.
排除标准
- •Patients who have already received a specific (or plan to receive in the coming 12 months) and dedicated program/global evaluation including education on the disease or treatments.
- •Patients with any physical or mental condition that may affect understanding of the intervention or adherence to treatment (e.g. major depression or substance/alcohol use - might have impact on the outcomes of interest in the study).
结局指标
主要结局
The change in patient knowledge of the disease.
时间窗: Visits Day 0 and Month 12
The primary endpoint will be the change in the SPAKE questionnaire
The change in patient knowledge of the disease.
时间窗: Visits Day 0 and Month 12
The primary endpoint will be the change in the SPAKE questionnaire
次要结局
- Assessment of health services resources use(Visit Month 12)
- Treatment(Visits Day 0 and Month 12)
- The ability to cope with the disease(Visits Day 0 and Month 12)
- Knowledge on b/tsDMARDs(Visits Day 0 and Month 12)
- Adherence to axSpA treatments(Visits Day 0 and Month 12)
- Disease activity(Visits Day 0 and Month 12)
- Number of comorbidities(Visit Month 12)
- Function change(Visits Day 0 and Month 12)
- Quality of life change(Visits Day 0 and Month 12)
- Work impairment(Visit Month 12)
- The patient's perception of the benefits of this type of initial global standardized review on patient's follow-up and the treating rheumatologist's perception of the benefits of this type of initial global standardized review on patient follow-up(Visit Month 12)
- The sources of information accessed by patients(Visits Day 0 and Month 12)
- Treatment(Visits Day 0 and Month 12)
- The ability to cope with the disease(Visits Day 0 and Month 12)
- Knowledge on b/tsDMARDs(Visits Day 0 and Month 12)
- Adherence to axSpA treatments(Visits Day 0 and Month 12)
- Disease activity(Visits Day 0 and Month 12)
- Number of comorbidities(Visit Month 12)
- Function change(Visits Day 0 and Month 12)
- Quality of life change(Visits Day 0 and Month 12)
- Work impairment(Visit Month 12)
- Assessment of health services resources use(Visit Month 12)
- The patient's perception of the benefits of this type of initial global standardized review on patient's follow-up and the treating rheumatologist's perception of the benefits of this type of initial global standardized review on patient follow-up(Visit Month 12)
- The sources of information accessed by patients(Visits Day 0 and Month 12)