De Vera Mary A, Sadatsafavi Mohsen, Tsao Nicole W, Lynd Larry D, Lester Richard, Gastonguay Louise, Galo Jessica, FitzGerald J Mark, Brasher Penelope, Marra Carlo A
Faculty of Pharmaceutical Sciences, University of British Columbia, 2405 Wesbrook Mall, Vancouver V6T 1Z3, Canada.
Trials. 2014 Dec 13;15:488. doi: 10.1186/1745-6215-15-488.
Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients. Pharmacists are suited to impact medication adherence given their training, skills, and frequent contact with patients. The Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS) trial involves an intervention leveraging mobile health (mHealth) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma.
METHODS/DESIGN: This study is a pragmatic pharmacy-based, cluster, randomized controlled trial with 12 months of intervention delivery and follow-up. Pharmacies (the clusters) will be randomized at a 1:1 ratio to provide intervention or usual care. The EmPhAsIS intervention consists of patient asthma education, short message service (SMS)-based monthly assessment of adherence, and follow-up of non-adherent individuals by community pharmacists. There are no inclusion or exclusion criteria for pharmacies. Patients are eligible if they: are 14 years of age or older, fill a prescription for inhaled corticosteroid (either monotherapy or in a combination inhaler with long-acting beta-agonists), have been diagnosed with asthma, possess a mobile phone with SMS capabilities, and have no communication difficulties such as inability to communicate in English, or significant impairment in vision, hearing, or speech. The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio, the ratio of the days of medication supplied to days in a given time interval. This study will also evaluate secondary outcomes including: asthma control, asthma-related quality of life, asthma-related hospital admissions, and use of reliever medications during the follow-up period. A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon.
Considering the prevalence of asthma, the extent of the non-adherence problem in this disease, and the availability of effective treatments, there is a tremendous potential to reduce the burden of asthma through improving adherence. This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management.
ClinicalTrials.gov identifier: NCT02170883; date of registration: 19 June 2014.
由于哮喘药物治疗方案需要长期使用，且患者会经历症状缓解期，因此特别容易出现依从性问题。鉴于药剂师所接受的培训、具备的技能以及与患者的频繁接触，他们适合对药物依从性产生影响。通过交互式短信增强药剂师在哮喘管理中的作用（EmPhAsIS）试验涉及一项利用移动健康（mHealth）技术来支持社区药房实践的干预措施，其假设是改善哮喘患者的药物依从性。
方法/设计：本研究是一项基于药房的实用整群随机对照试验，干预实施及随访为期12个月。药房（整群）将按1:1的比例随机分组，以提供干预措施或常规护理。EmPhAsIS干预措施包括患者哮喘教育、基于短信服务（SMS）的每月依从性评估以及社区药剂师对未依从个体的随访。对药房没有纳入或排除标准。患者符合以下条件即为 eligible：年龄在14岁及以上、开具吸入性糖皮质激素处方（单药治疗或与长效β受体激动剂联合吸入器）、已被诊断为哮喘、拥有具备短信功能的手机且没有沟通障碍，如无法用英语交流、视力、听力或言语有严重障碍。主要结局是通过药物持有率确定的吸入性糖皮质激素依从性，即给定时间间隔内供应药物的天数与天数的比率。本研究还将评估次要结局，包括：哮喘控制、哮喘相关生活质量、哮喘相关住院以及随访期间缓解药物的使用。将使用概率决策分析模型进行嵌套式经济评估，从社会角度对干预措施与常规护理在10年时间范围内进行成本效益分析。
考虑到哮喘的患病率、该疾病中不依从问题的程度以及有效治疗方法的可用性，通过提高依从性来减轻哮喘负担具有巨大潜力。这是第一项基于移动通信技术、涉及社区药剂师参与哮喘管理的干预措施研究。
ClinicalTrials.gov标识符：NCT02170883；注册日期：2014年6月19日。
