Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- BIOSECURE patient self-questionnaire
研究概览
简要总结
To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation.
The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP.
Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Non-radiological spondyloarthritis diagnosis (ASAS criteria)
- •Anti-TNFalpha biological treatment initiation required
- •Adult patient (age>18years)
- •Capacity to understand self-questionnaires and address questions
- •Patient accepting to attend a therapeutic education program (TEP)
排除标准
- •Previous Anti-TNFalpha biological treatment
- •Previous attendance to a TEP concerning biological or spondyloarthritis
- •Contraindication to Anti-TNFalpha treatment
- •Associated and unbalanced diseases
结局指标
主要结局
BIOSECURE patient self-questionnaire
时间窗: Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation
Patients will address questions and role play scenario evaluating cognitive and adaptive competences. The Biosecure score is between 0 and 100.
次要结局
未报告次要终点