Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders
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 b...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-06-01
|
| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-025-01748-2 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849726055750828032 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Jia Zhou |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-b38ebb47426b4bc091482cc45b34d8be |
| institution | DOAJ |
| issn | 2398-6352 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Digital Medicine |
| spelling | doaj-art-b38ebb47426b4bc091482cc45b34d8be2025-08-20T03:10:18ZengNature Portfolionpj Digital Medicine2398-63522025-06-018111010.1038/s41746-025-01748-2Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disordersJia Zhou0Qian Zhai1Han Qi2Xiaolei Jin3Cunli Xiao4Wenxiu Li5Junwei Song6Lei Feng7Haibo Wang8Chengcheng Dong9Zibo Yu10Yuan Feng11Gang Wang12Fang Yan13Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Tongzhou District Psychiatric HospitalXicheng District Pingan Hospital of Beijing MunicipalityBeijing Haidian Psychological Rehabilitation HospitalBeijing Pinggu District Psychiatric HospitalBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityClinical Research Institute, Institute of Advanced Clinical Medicine, Peking UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityAbstract 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).https://doi.org/10.1038/s41746-025-01748-2 |
| spellingShingle | 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 Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders npj Digital Medicine |
| title | Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders |
| title_full | Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders |
| title_fullStr | Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders |
| title_full_unstemmed | Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders |
| title_short | Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders |
| title_sort | randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders |
| url | https://doi.org/10.1038/s41746-025-01748-2 |
| work_keys_str_mv | AT jiazhou randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT qianzhai randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT hanqi randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT xiaoleijin randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT cunlixiao randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT wenxiuli randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT junweisong randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT leifeng randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT haibowang randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT chengchengdong randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT ziboyu randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT yuanfeng randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT gangwang randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders AT fangyan randomizedclinicaltrialofadigitalmedicationsystemtoenhanceadherenceinpatientswithseverementaldisorders |