Melvin Emilie, Cushing Anna, Tam Anne, Kitada Ruri, Manice Melissa
Department of Clinical Research, Cohero Health, New York, USA.
Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, USA.
BMJ Open Respir Res. 2017 Aug 16;4(1):e000204. doi: 10.1136/bmjresp-2017-000204. eCollection 2017.
Non-adherence to asthma daily controller medications is a common problem, reported to be responsible for 60% of asthma-related hospitalisations. The mean level of adherence for asthma medications is estimated to be as low as 22%. Therefore, objective measurements of adherence to medicine are necessary. This virtual observational study is designed to measure the usability of an electronic monitoring device platform that measures adherence. Understanding how patients use the BreatheSmart mobile technology at home is essential to assess its feasibility as a solution to improve medication adherence. We anticipate this approach can be applied to real-world environments as a cost-effective solution to improve medication adherence.
This is a virtual 6-month observational study of 100 adults (≥18 years) with an asthma diagnosis, using inhaled corticosteroids for at least 3 months. Participants will be recruited in the USA through ad placements online. All participants receive wireless Bluetooth-enabled inhaler sensors that track medication usage and an mSpirometer capable of clinical-grade lung function measurements, and download the BreatheSmart mobile application that transmits data to a secure server. All analyses are based on an intention-to-treat. Usability is assessed by patient questionnaires and question sessions. Simple paired t-test is used to assess significant change in Asthma Control Test score, quality of life (EuroQol-5D questionnaire) and lung function.
No ethical or safety concerns pertain to the collection of these data. Results of this research are planned to be published as soon as available.
NCT03103880.
不坚持使用哮喘日常控制药物是一个常见问题，据报道，60%的哮喘相关住院病例与此有关。哮喘药物的平均依从水平估计低至22%。因此，有必要对药物依从性进行客观测量。这项虚拟观察性研究旨在测量一种用于测量依从性的电子监测设备平台的可用性。了解患者在家中如何使用BreatheSmart移动技术对于评估其作为改善药物依从性解决方案的可行性至关重要。我们预计这种方法可以作为一种经济有效的解决方案应用于现实环境，以提高药物依从性。
这是一项针对100名确诊哮喘的成年人（≥18岁）进行的为期6个月的虚拟观察性研究，这些患者使用吸入性糖皮质激素至少3个月。参与者将通过在美国的在线广告招募。所有参与者都将获得能够跟踪药物使用情况的无线蓝牙吸入器传感器和一台能够进行临床级肺功能测量的微型肺活量计，并下载将数据传输到安全服务器的BreatheSmart移动应用程序。所有分析均基于意向性分析。通过患者问卷和问答环节评估可用性。使用简单配对t检验评估哮喘控制测试评分、生活质量（欧洲五维健康量表问卷）和肺功能的显著变化。
收集这些数据不存在伦理或安全问题。本研究结果计划尽快发表。
NCT03103880。
