NL-OMON28450招募中不适用
A cluster Randomised Controlled Trial of the effectiveness, usability and acceptability of a smart inhaler programme in asthma patients: the ACCEPTANCE study
eiden University Medical Center0 个研究点目标入组 242 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 242
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Doctor-diagnosed asthma (when recruited via general practices or public channels), self-reported asthma diagnosis (when recruited via pharmacies - asthma diagnosis will be confirmed by GP at study end (T12))
- •2. Partially controlled or uncontrolled asthma, defined as an ACQ-5 score =0.75 at the first visit T-1
- •3. Use of Symbicort® Turbuhaler® as maintenance therapy for at least eight weeks before entering the run-in period
- •4. Being non-adherent during the run-in period, defined as an adherence rate of below 80% over the third and fourth week of the run-in period. Adherence is defined as the number of adherent days as a proportion of the total number of days during the third and fourth week of the run-in period.
- •5. In possession of a smartphone
- •6. Written informed consent
排除标准
- •1. Age < 18 years
- •2. Use of SMART regimen (Symbicort Maintenance And Reliever Therapy) by taking Symbicort as reliever in response to symptoms
- •3. Change in inhaled corticosteroids (ICS) dose in the 4 weeks prior to the run-in period
- •4. Use of systemic corticosteroids in the 4 weeks prior to the run-in period, including maintenance therapy
- •5. Current use of biologics, including anti-IL-5 (mepolizumab, reslizumab, benralizumab) or anti-IgE (omalizumab)
- •6. Diagnosis of COPD, interstitial lung diseases, bronchiectasis or other significant respiratory condition
- •7. Malignancy with life expectancy < 1 year
- •8. Pregnancy
- •9. Inability to understand Dutch
- •10. Any other condition which, at the GPs and/or investigator’s discretion, is believed may present a safety risk or impact the study results
研究者
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