Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders.
rct · Level II
Where this comes from
- Record sourced from PubMed, PMID 40467762.
- Also identified by DOI 10.1038/s41746-025-01748-2 and PMC identifier 12137551.
- Licence recorded as CC BY-NC-ND.
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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).