Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders

IF 15.1 1区医学 Q1 HEALTH CARE SCIENCES & SERVICES

NPJ Digital Medicine Pub Date : 2025-06-05 DOI:10.1038/s41746-025-01748-2

Jia Zhou, Qian Zhai, Han Qi, Xiaolei Jin, Cunli Xiao, Wenxiu Li, Junwei Song, Lei Feng, Haibo Wang, Chengcheng Dong, Zibo Yu, Yuan Feng, Gang Wang, Fang Yan

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Abstract

To evaluate the effectiveness of a digital medication system in improving adherence among patients with serious mental disorders (SMD), we conducted a cluster-randomized controlled trial across 30 communities in Beijing. Participants, aged 18–65 years, were diagnosed with schizophrenia or bipolar disorder and either received intermittent medication or refused treatment. Recruitment occurred from September 2, 2022, to January 12, 2023. The intervention group received a digital medication system. The control group used an online medication diary. The primary outcome was poor adherence, defined as missing 20% or more of prescribed doses at 12 months. Among 216 recruited patients, 206 completed the study. The intervention group showed significantly higher adherence (84/108 vs. 23/108), with an adjusted risk difference of 52.34% (95% CI: 34.65%–70.03%; P < 0.0001). This trial provides the first robust evidence that the digital medication system can significantly improve medication adherence in patients with SMD. Trial Registration: The trial was registered on the Chinese Clinical Trial Registry (chictr.org.cn) on May 29, 2022 (ChiCTR-ICR-2200060359).

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提高严重精神障碍患者依从性的数字药物系统的随机临床试验

为了评估数字医疗系统在改善严重精神障碍患者依从性方面的有效性，我们在北京30个社区进行了一项集群随机对照试验。参与者年龄在18-65岁之间，被诊断患有精神分裂症或双相情感障碍，要么接受间歇性药物治疗，要么拒绝治疗。招聘时间为2022年9月2日至2023年1月12日。干预组使用数字医疗系统。对照组使用在线用药日记。主要结局是依从性差，定义为在12个月时缺少20%或更多的处方剂量。在216名被招募的患者中，206名完成了研究。干预组的依从性明显高于对照组（84/108 vs. 23/108），调整后的风险差异为52.34% (95% CI: 34.65% ~ 70.03%；P < 0.0001)。该试验首次提供了强有力的证据，证明数字药物系统可以显著提高SMD患者的药物依从性。试验注册：该试验于2022年5月29日在中国临床试验注册中心（chictr.org.cn）注册（ChiCTR-ICR-2200060359）。

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来源期刊

NPJ Digital Medicine Multiple-

CiteScore

25.10

自引率

3.30%

发文量

170

审稿时长

15 weeks

期刊介绍： npj Digital Medicine is an online open-access journal that focuses on publishing peer-reviewed research in the field of digital medicine. The journal covers various aspects of digital medicine, including the application and implementation of digital and mobile technologies in clinical settings, virtual healthcare, and the use of artificial intelligence and informatics. The primary goal of the journal is to support innovation and the advancement of healthcare through the integration of new digital and mobile technologies. When determining if a manuscript is suitable for publication, the journal considers four important criteria: novelty, clinical relevance, scientific rigor, and digital innovation.