Hollenbach JessicaP, Simoneau Tregony, Sun Ye, Becene Iris, Almeida Sigrid, Langton Christine, Flores Glenn
Connecticut Children's Medical Center, 282 Washington Street, Hartford, CT, 06106, USA.
Department of Pediatrics, Uconn Health School of Medicine, Farmington, CT, 06030, USA.
Contemp Clin Trials Commun. 2021 Feb 6;21:100706. doi: 10.1016/j.conctc.2021.100706. eCollection 2021 Mar.
NON-ADHERENCE TO MEDICATION IS COMMON: Current methods of assessing adherence are inaccurate. Electronic monitoring devices (EMDs) may more accurately assess adherence, but are not currently used in practice. The design, methods, and participant baseline characteristics are described for a pilot trial of the effects of an EMD on asthma medication adherence in a pediatric population.This was a pilot, randomized, controlled trial of children with persistent asthma managed with daily inhaled corticosteroids (ICS). Seventy-five children were randomized 2:1 to receive either two EMDs (one for ICS and one for rescue) linked via Bluetooth to a mobile application (app) or standard of care (controls). EMDs recorded dates and times of inhaler actuations and the app sent daily medication reminders to participants. Controls were provided standard care. Medication adherence was measured using pharmacy refill records and self-report, whereas EMD data were used to measure adherence in the intervention group. Secondary outcomes included asthma control, pulmonary function, and quality of life.
One hundred sixty children were screened for eligibility, with 123 individuals excluded. Seventy-five children were enrolled, with 25 allocated to the control group and 50 to the intervention. The mean age of participants is 12 years old (±2.9), with equal proportions of male and female children; 45% are Latinx and 19% African-American; 77% report Medicaid or CHIP coverage. Half of participants have moderate persistent asthma and 48% had marginally controlled asthma at time of enrollment. There were no significant inter-group differences in baseline sociodemographic characteristics.
This pilot successfully reached target populations and met recruitment and enrollment goals. It is addressing an important knowledge gap by evaluating the effects of an EMD with a mobile app on adherence rates, findings which could prove useful in determining whether routine use of EMDs in clinical practice help children achieve better asthma control and outcomes.
NCT03734861.
当前评估依从性的方法并不准确。电子监测设备（EMD）可能会更准确地评估依从性，但目前在实际中尚未使用。本文描述了一项针对儿科人群中EMD对哮喘药物治疗依从性影响的试点试验的设计、方法和参与者基线特征。
这是一项针对持续哮喘儿童的试点、随机、对照试验，这些儿童采用每日吸入皮质类固醇（ICS）进行治疗。75名儿童按2:1随机分组，分别接受两个通过蓝牙连接到移动应用程序（app）的EMD（一个用于ICS，一个用于急救）或标准治疗（对照组）。EMD记录吸入器启动的日期和时间，app向参与者发送每日用药提醒。对照组接受标准护理。使用药房配药记录和自我报告来衡量药物治疗依从性，而EMD数据用于衡量干预组的依从性。次要结果包括哮喘控制、肺功能和生活质量。
筛选了160名儿童以确定其是否符合条件，其中123人被排除。75名儿童入组，25人被分配到对照组，50人被分配到干预组。参与者的平均年龄为12岁（±2.9），男童和女童比例相等；45%为拉丁裔，19%为非裔美国人；77%报告有医疗补助或儿童健康保险计划覆盖。一半的参与者患有中度持续性哮喘，48%在入组时哮喘控制不佳。两组在基线社会人口统计学特征方面没有显著差异。
该试点成功覆盖了目标人群，达到了招募和入组目标。通过评估带有移动应用程序的EMD对依从率的影响，填补了一个重要的知识空白，这些发现可能有助于确定在临床实践中常规使用EMD是否有助于儿童实现更好的哮喘控制和治疗效果。
NCT0373486
