COmorbidities and EDucation in SpondyloArthritis Study (COMEDSPA) Evaluation of Standardized Follow-up in Axial Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 2
- 主要终点
- self-assessment/self-management
研究概览
简要总结
Giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic "environment".
This study with its two parts should be able to demonstrate:
- The importance of a systematic evaluation of comorbidities in Spondyloarthritis,
- The utility of a nurse-led program of self-assessment and self-management of the disease
详细描述
Patients with spondyloarthritis will be invited by their rheumatologists to participate at this study in 21 centers in France.
500 patients are planned to be included.
After written informed consent will be obtained, the patients will be randomized in two arms:
- comorbidities
- self-assessment/self-management The patients will be seen again in the same center 12 months later in order to collect the outcome measures
The two primary objectives of this trial are :
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
- •Male or female over 18 and under 80 years
- •Axial Spondyloarthritis according to the ASAS criteria (Assessment of SpondyloArthritis international Society)
- •Disease duration of at least one year
- •Activity of SpA to be stable according to the treating rheumatologist for at least three months before the date of inclusion
- •Lack of elective surgery during the 6 months after inclusion
- •Able to understand and adhere to the study treatments
- •Development of a medical examination results given to the patient
- •Informed Consent signed and dated
排除标准
- •Pregnant women (any method of contraception will be accepted)
- •Patients who have had a change in the treatment of SpA during the 3 months prior to inclusion
- •History of alcoholism, drug addiction, psychological problems, severe comorbidities that could possibly invalidate informed consent or limit patient compliance with the study protocol
- •No affiliation to a social security regime
结局指标
主要结局
self-assessment/self-management
时间窗: 1 year later
The level of coping after 12 months based on the question#8 ( 0-10 NRS) of the RAID score. Such outcome will be evaluated at both the baseline and the one year visits in both groups.
Comorbidities
时间窗: 1 year later
Changes after 12 months in the comorbidity composite score. Such composite score has been established prior the study and is taking into account the optimal management of patients (e.g. Normal blood pressure, no smoking,....) . Such score will be calculated at baseline and at the one year visit in the two groups.
次要结局
- Frequency of compliance with general recommendations on vaccinations, screening for certain cancers and osteoporosis screening(1 year later)
- Impact of self-assessment by the patient of his/her Spondyloarthritis activity (ASDAS-CRP (C Reactive Protein), BASDAI) on the activity and severity of the disease(1 year later)
- Frequency of comorbidities in Spondyloarthritis(1 year later)
- Patient compliance program self-management of Spondyloarthritis(1 year later)