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
- 1
- 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
研究组 & 干预措施
comorbidities
Evaluation of the prevalence and the presence of the risks factors of the four most frequently observed comorbidities in spondyloarthritis (cardiovascular diseases, cancers, infections osteoporosis and gastro-intestinal) as it is recommended by the French Society of Rheumatology.
干预措施: Comorbidities (detection/prevention) (Behavioral)
self-assessment
During the initial visit, the clinical research nurse exempt a learning program of assessment of disease activity/severity :
- for assessing the activity in SpA;
- for the calculation of BASDAI and the ASDAS-CRP
- for the transfer technique and for the calculation of the disease activity on a monthly basis during the next 12 months.
- for the risk of tobacco exposure
- for the benefit of an NSAID intake in case of painful episode of the disease
- for the benefit of home exercises
- for the spine and indication of a treatment under the supervision of a physiotherapist in case of severe disease
- for learning the patient to calculate his BASDAI and ASDAS-CRP Then, the patient will return home with his calculator and his notebook. Each month, the patient will be asked to perform the BASDAI and ASDAS-CRP calculations and to report the data on the notebook. 12 months later, the patient comes for a visit in the current practice to assess both such program and comorbidities.
干预措施: self-assessment/self-management (Behavioral)
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)