Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Department of General Practice & Elderly Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
BMJ Open. 2022 Jun 13;12(6):e059929. doi: 10.1136/bmjopen-2021-059929.
Medication adherence and inhaler technique in patients with asthma remain suboptimal. A digital, smart spacer may support personalised adherence and inhaler technique education. The aim of this study is to assess the feasibility of undertaking a definitive randomised controlled trial of personalised, smart spacer data-driven education and explore clinical benefits.
We present the design of the multicentre, randomised controlled OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE feasibility trial of 2 months. Patients will be recruited from four Dutch general practices. At t=-1, patients with asthma ≥18 years using inhaled corticosteroids±long-acting beta-agonists±short-acting beta-agonists administered with a pressurised-metered-dose-inhaler and spacer (n=40) will use a smart spacer for 1 month. The rechargeable CE-marked smart spacer (Aerochamber Plus with Flow Vu) includes a sensor that monitors adherence and inhalation technique to prescribed dosing regimen of both maintenance and reliever inhalers. After 1 month (t=0), patients are 1:1 randomised into two groups: control group (usual care) versus intervention group (personalised education). At t=-1, t=0 and t=1 month, the Asthma Control Questionnaire (ACQ), Work Productivity and Activity Impairment (WPAI) questionnaire and Test of Adherence to Inhalers (TAI) are administered and fractional exhaled nitric oxide (FeNO) is assessed. At t=0 and t=1, spirometry is performed. At t=1, usability and satisfaction will be analysed using the System Usability Scale and interviews with patients and healthcare providers. Primary outcome is the overall feasibility of a definitive trial assessed by patient recruitment speed, participation and drop-out rate. Secondary outcomes are patient and healthcare provider satisfaction and exploratory clinical outcomes are adherence, inhaler technique, TAI score, FeNO, lung function, ACQ and WPAI.
Ethical approval was obtained from the RTPO in Leeuwarden, Netherlands (number: NL78361.099.21). Patients will provide written informed consent. Study findings will be disseminated through conferences and peer-reviewed scientific and professional journals.
NL9637.
哮喘患者的药物依从性和吸入器技术仍然不理想。数字智能吸入器可能有助于个性化的药物依从性和吸入器技术教育。本研究的目的是评估开展个性化、智能吸入器数据驱动教育的确定性随机对照试验的可行性，并探索其临床获益。
我们介绍了这项多中心、随机对照的 OUtcomes following Tailored Education and Retraining：Studying Performance and AdherenCE 可行性试验的设计，试验时间为 2 个月。患者将从荷兰的 4 个普通诊所招募。在 t=-1 时，≥18 岁、正在使用吸入皮质激素±长效β激动剂±短效β激动剂、并使用压力计量吸入器和储雾罐（n=40）的哮喘患者将使用智能吸入器 1 个月。可充电的 CE 标记智能吸入器（Aerochamber Plus with Flow Vu）包括一个传感器，可监测维持和缓解吸入器的规定剂量方案的药物依从性和吸入技术。1 个月后（t=0），患者 1:1 随机分为两组：对照组（常规护理）和干预组（个性化教育）。在 t=-1、t=0 和 t=1 时，患者将接受哮喘控制问卷（ACQ）、工作效率和活动障碍（WPAI）问卷和吸入器依从性测试（TAI）的评估，并测量呼出气一氧化氮（FeNO）。在 t=0 和 t=1 时，进行肺功能检查。在 t=1 时，使用系统可用性量表和对患者和医疗保健提供者的访谈分析可用性和满意度。主要结局是通过患者招募速度、参与率和失访率评估确定性试验的总体可行性。次要结局是患者和医疗保健提供者的满意度，探索性临床结局是药物依从性、吸入器技术、TAI 评分、FeNO、肺功能、ACQ 和 WPAI。
荷兰 Leeuwarden RTPO 已批准该研究（编号：NL78361.099.21）。患者将提供书面知情同意书。研究结果将通过会议和同行评议的科学和专业期刊传播。
NL9637。
