Objective

We perform a randomized trial to test the impact of electronic pill bottles with audiovisual reminders on oral disease modifying therapy (DMT) adherence in people with MS (PwMS).

Methods

Adults with multiple sclerosis (MS) taking an oral DMT were randomized 1:1 for 90 days to remote smartphone app- and pill bottle-based (a) adherence monitoring, or (b) adherence monitoring with audiovisual medication reminders. Optimal adherence was defined as the proportion of doses taken ±3 h of the scheduled time. Numbers of missed pills and pills taken early, on time, late, and extra were recorded. A multivariable regression model tested possible associations between optimal adherence and age, MS duration, cognitive functioning, and number of daily prescription pills.

Results

85 participants (66 female; mean age 44.9 years) took dimethyl/diroximel fumarate (n = 49), fingolimod (n = 26), or teriflunomide (n = 10). Optimal adherence was on average higher in the monitoring with reminders arm (71.4%) than the monitoring only arm (61.6%; p = 0.033). In a multivariable model, optimal adherence was less likely in younger participants (p < 0.001) and those taking more daily prescription pills (p < 0.001). In the monitoring only arm, 4.0% of doses were taken early, 61.6% on time, 5.6% late, 4.4% in excess, and 24.4% were missed. In the reminders arm, these proportions were 3.4%, 71.4%, 3.7%, 8.7%, and 12.8%, respectively.

Conclusion

We map real-world oral DMT adherence patterns using mHealth technology. PwMS who received medication reminders had higher optimal adherence. Nonadherence was more nuanced than simply missing pills. Developing strategies to improve adherence remains important in longitudinal MS care.

中文翻译：

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用于监测和促进多发性硬化症患者服药依从性的电子药瓶：一项随机虚拟临床试验

客观的

我们进行了一项随机试验，以测试带有视听提醒的电子药瓶对 MS (PwMS) 患者口腔疾病改善疗法 (DMT) 依从性的影响。

方法

服用口服 DMT 的多发性硬化症 (MS) 成人在 90 天内按 1:1 随机分配到基于远程智能手机应用程序和药瓶的 (a) 依从性监测，或 (b) 使用视听药物提醒的依从性监测。最佳依从性定义为在预定时间 ±3 小时内服用的剂量比例。记录错过的药丸和提前、准时、延迟和额外服用的药丸的数量。多变量回归模型测试了最佳依从性与年龄、MS 持续时间、认知功能和每日处方药数量之间的可能关联。

结果

85 名参与者（66 名女性；平均年龄 44.9 岁）服用富马酸二甲酯/二羟肟酸 ( n  = 49)、芬戈莫德 ( n  = 26) 或特立氟胺 ( n  = 10)。与仅监测组 (61.6%；p  = 0.033)相比，带提醒组的监测 (71.4%) 的最佳依从性平均更高。在一个多变量模型，最优坚持是不太可能在更年轻的参与者（p  <0.001）和服用多种处方每天丸（p  <0.001）。在仅监测组中，4.0% 的剂量提前服用，61.6% 按时服用，5.6% 晚服用，4.4% 过量服用，24.4% 漏服。在提醒部分，这些比例分别为 3.4%、71.4%、3.7%、8.7% 和 12.8%。

结论

我们使用 mHealth 技术绘制了真实世界的口腔 DMT 依从性模式。收到药物提醒的 PwMS 具有更高的最佳依从性。不依从比简单地漏药更微妙。制定提高依从性的策略在纵向 MS 护理中仍然很重要。