Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- adherence to biotherapies
研究概览
简要总结
The management of chronic inflammatory rheumatism, including spondyloarthritis (SpA), has been revolutionized in recent decades with the arrival of biological therapy. The success of the current therapeutic strategy is also based on therapeutic compliance. If therapeutic adherence in rheumatoid arthritis patient (RA) is only 66%, it seems even worse in SpA. Few studies report quantitatively the adherence of SpA patients, as well as the predictive or associated factors. The objective of this study is to assess the patient adherence to biologics in patients with axial SpA (SpAax), and to investigate factors influencing this adherence, in particular the association with vaccination coverage, dietary behavior, and digital health tools.
详细描述
Multicentric cross-sectional survey of patients seen in the context of a rheumatology consultation or hospitalization.
On the occasion of a single visit in consultation or hospitalization, an anonymous self-questionnaire will be distributed to patients undergoing SpAax follow-up to assess their compliance with biologic drugs, their vaccination coverage, their diet, the presence of a fibromyalgia syndrome or inflammatory bowel disease, intestinal disorders, regular physical activity and sedentary lifestyle, the frequency and mode of use of mobile applications and/or connected objects related to health, the presence of catastrophic thoughts and the presence of anxiety and depressive disorders. Medical data relevant to routine care will be collected.(Age, sex, weight, height, tobacco and alcohol use, disease characteristics, SpA treatment, comorbidities)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient >18 years old with axial spondyloarthritis according to ASAS criteria and treated with biotherapy.
- •French-speaking, without any understanding problems.
排除标准
- •Patients under curatorship, guardianship or other legal protection
- •Patients refusing to consent to participate in research
- •Pregnant and breastfeeding women.
结局指标
主要结局
adherence to biotherapies
时间窗: Day 1
Proportion of spondyloarthritis patients with good adherence to biotherapies. Adherence was assessed by Girerd's self-administered questionnaire score. Six questions self-questionnaire, Yes =1 and No = 0 Patients are then classified as follows: * Score = 0: Good adherence to therapy * Score = 1 or 2: minimal adherence problem * Score \> 3: Poor adherence to therapy
次要结局
- Proportion of patients who received influenza and pneumococcal vaccinations(Day 1)
- Proportion of vaccinated patients with good adherence to biologic treatment.(Day 1)
- Proportion of Inflammatory bowel disease (IBD) patients with good adherence to biologic treatment(Day 1)
- Proportion of patients using digital health tools with good adherence to biologic treatment.(Day 1)
- Proportion of patients on a diet and good adherence to biologic treatment.(Day 1)
- Proportion of patients with regular physical activity and good adherence to biologic treatment.(Day 1)
- Proportions of patients with catastrophic thoughts and good adherence to biologic treatment.(Day 1)
- Proportions of patients with anxiety and depressive disorders in patients with good adherence to biologic treatment(Day 1)
- Proportion of fibromyalgia patients with good adherence to biologic treatment(Day 1)