Presenteeism in Severe Asthma Treated by Biotherapyasthma (PRESATHMA)
Factors Associated With the Evolution of Presenteeism Under Biotherapy in Severe Asthma
Severe asthma is a condition characterized by a lower sensitivity to high doses of inhaled corticosteroids combined with a second controller, most often a long-acting bronchodilator. It concerns approximately 5% of asthmatics. Treatment failure and co-morbidities induced by systemic corticosteroid therapy can cause debilitating dyspnea, limited physical activity, and impaired quality of life. Severe asthma could therefore be associated with major presenteeism, defined as the presence of an employee at work despite his health issues and which implies a limitation of the employee's productive capacity. Uncontrolled asthma and co-morbidities of asthma have been shown to be associated with a decrease in work productivity that includes absenteeism and presenteeism. Although there is little data, a recent study found a decline in work productivity in severe asthma. Various factors associated with presenteeism could be involved, such as asthma control, frequency and severity of exacerbations, comorbidities, or treatments.
Biotherapies targeting the signaling pathways involved in airway inflammation improve asthma control, decrease the frequency of asthma exacerbations which are major determinants of quality of life, improve lung function, and allow oral steroid sparing. Biotherapies could therefore be associated with a decrease in presenteeism.
The objective of the study is to describe the evolution of presenteeism at work, evaluated by the WPAI: Asthma, after 6 months of treatment by biotherapy and to identify factors associated with this evolution
研究概览
地位
条件
研究类型
注册 (预期的)
联系人和位置
学习地点
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Lille、法国
- 招聘中
- Hop Calmette Chu Lille
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Severe asthma defined as the use of a high doses of inhaled corticosteroids combined with a second controller (GINA 4) and / or oral corticosteroid therapy > 50% of the year
- Eligible for biotherapy according to the investigator's decision
- Holders of an employment contract for at least 8 days
- Written non-opposition to participate in the study after information
- Social protection affiliation
Exclusion Criteria:
- Existence of another chronic pulmonary disease (bronchiectasis, COPD, diffuse interstitial lung disease, neuromuscular pathology, etc.) or cardiac (cardiac rhythm disorder, ischemic heart disease, etc.) significant according to the investigator's judgment
- Psychiatric disorder
- Pregnancy
- Persons under guardianship
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in presenteeism
大体时间:At 6 months
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Change Questionnaire Work Productivity and activity impairment : Asthma (WPAI : Asthma) - question 5 (Q5) after 6 months of biotherapy The WPAI-question 5 ranges from 0 to 10, a higher score meaning a worse outcome
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At 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Correlation between the WPAI : Asthma- Q5 score and the ACQ-6 score
大体时间:at baseline
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Association between presenteeism and asthma control Asthma Control Questionnaire (ACQ) is simple questionnaire to measure the adequacy of asthma control and change in asthma control, 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)
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at baseline
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Correlation between the WPAI : Asthma- Q5 score and the mMRC score
大体时间:at baseline
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Association between presenteeism and exercise dyspnea at baseline the mMRC (Modified Medical Research Council) Dyspnea Scale,The 1-5 stage scale is used alongside the questionnaire to establish clinical grades of breathlessness.
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at baseline
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Correlation between the WPAI : Asthma- Q5 score and FEV1, la FVC and RV.
大体时间:at baseline
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Association between presenteeism and airways obstruction at baseline
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at baseline
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Correlation between the WPAI : Asthma- Q5 score and the STAI-Y2 score
大体时间:at baseline
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Association between presenteeism and anxiety at baseline tate-Trait Anxiety Inventory, STAI-Y2 (STAI-Y2), consists of 20 sentences assessing the subject's usual emotional state.Each answer to an item in the STAI-Y is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest degree of anxiety.
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at baseline
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Correlation between the WPAI : Asthma- Q5 score and the Nijmegen score
大体时间:at baseline
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Association between presenteeism and hyperventilation symptoms at baseline
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at baseline
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Correlation between the WPAI : Asthma- Q5 score and the SNOT-22 score
大体时间:at baseline
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Association between presenteeism and sino-nasal symptoms at baseline
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at baseline
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Correlation between the WPAI : Asthma- Q5 score and the AQLQ score
大体时间:at baseline
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Association between presenteeism and quality of life at baseline
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at baseline
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Correlation between the WPAI : Asthma- Q5 score and the daily dose of oral corticosteroids
大体时间:at baseline
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Association between presenteeism and daily dose of oral corticosteroids at baseline
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at baseline
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Correlation between the WPAI : Asthma- Q5 score and the cumulative dose over 6 months of oral corticosteroids
大体时间:at baseline
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Association between presenteeism and cumulative dose over 6 months of oral corticosteroids at baseline
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at baseline
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Correlation between the change in the WPAI : Asthma- Q5 score and in the ACQ-6 score
大体时间:at baseline and at 6 months
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Association between the change in presenteeism and in asthma control after 6 months of biotherapy
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at baseline and at 6 months
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Correlation between the change in the WPAI : Asthma- Q5 score and in the mMRC score
大体时间:at baseline and at 6 months
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Association between the change in presenteeism and in exercise dyspnea after 6 months of biotherapy
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at baseline and at 6 months
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Correlation between the change in the WPAI : Asthma- Q5 score and in FEV1 and R5-R20
大体时间:at baseline and at 6 months
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Association between the change in presenteeism and in airways obstruction after 6 months of biotherapy
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at baseline and at 6 months
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Correlation between the change in the WPAI : Asthma- Q5 score and in the STAI-Y2 score
大体时间:at baseline and at 6 months
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Association between the change in presenteeism and in anxiety after 6 months of biotherapy
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at baseline and at 6 months
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Correlation between the change in the WPAI : Asthma- Q5 score and in the Nijmegen score
大体时间:at baseline and at 6 months
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Association between the change in presenteeism and in hyperventilation symptoms after 6 months of biotherapy
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at baseline and at 6 months
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Correlation between the change in the WPAI : Asthma- Q5 score and in the SNOT-22 score
大体时间:at baseline and at 6 months
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Association between the change in presenteeism and in sino-nasal symptoms after 6 months of biotherapy
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at baseline and at 6 months
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Correlation between the change in the WPAI : Asthma- Q5 score and in the AQLQ score
大体时间:at baseline and at 6 months
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Association between the change in presenteeism and in quality of life after 6 months of biotherapy
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at baseline and at 6 months
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• Correlation between the change in the WPAI : Asthma- Q5 score and in the daily dose of oral corticosteroids
大体时间:at baseline and at 6 months
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Association between the change in presenteeism and in the daily dose of oral corticosteroids after 6 months of biotherapy
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at baseline and at 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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