BACKGROUND Poor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations. METHODS This single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively. RESULTS Seventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07, P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03, P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80-100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%, P < .001) and dry powder capsules (90 ± .10% vs. 80 ± 21%, P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%, P < .001). No significant differences in QoL were found between the two groups. CONCLUSION Participants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed. TRIAL REGISTRATION ClinicalTrials.gov: NCT02386722, Registered 14 February 2014.

中文翻译：

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为促进慢性肺病患者依从性而量身定制的干预措施是否会加剧病情恶化？一项随机对照试验。

背景技术不良的药物依从性在慢性肺患者中是常见的，从而导致健康结果降低和医疗保健成本增加。这项研究旨在调查听觉提示和支持电话对哮喘和COPD患者坚持吸入治疗的影响，并确定其对病情加重的影响。方法这项单盲随机对照试验研究了在非卧床环境中6个月内哮喘和COPD患者的情况。干预措施包括每日闹钟和支持电话，每当未按规定使用救援药物加倍或吸入药物时使用。主要结局是下一次加重的时间。病情加重的频率，对药物的依从性和生活质量评分是次要结果。使用Cox和Poisson回归分别确定加重时间和加重频率的干预效果。结果有75名参与者被分配到干预组，有74名参与者进行了常规随访。在6.2个月的中位随访期间，干预组和对照组分别有22％和28％的病情恶化了至少一次。干预对首次发作的时间没有影响（HR 0.65，95％CI 0.21至2.07，P = 0.24），但显示出发作频率降低39％的趋势（RR = 0.61，95％CI 0.35至1.03， P = .070）。干预组有更多的天数，其中80％至100％的患者坚持使用粉扑吸入器（82±14％对60±30％，P <.001）和干粉胶囊（90±.10％对80±21％） ，P = 0.01）。干预组参与者使用粉扑吸入器的时间依从性更高（69±25％比51±33％，P <.001）。两组之间的QoL差异均无统计学意义。结论参加干预组的参与者服用吸入药物的时间和服药时间明显延长，从而导致加重频率降低的趋势。但是，未观察到下一次加重时间的影响。试验注册ClinicalTrials.gov：NCT02386722，2014年2月14日注册。结论参加干预组的参与者服用吸入药物的时间和服药时间明显延长，从而导致加重频率降低的趋势。但是，未观察到下一次加重时间的影响。试验注册ClinicalTrials.gov：NCT02386722，2014年2月14日注册。结论参加干预组的参与者服用吸入药物的时间和服药时间明显延长，从而导致加重频率降低的趋势。但是，未观察到下一次加重时间的影响。试验注册ClinicalTrials.gov：NCT02386722，2014年2月14日注册。