Feasibility and preliminary effectiveness of electronic medication monitoring system to improve antipsychotic adherence: a type 1 effectiveness-implementation hybrid pilot study

Schizophrenia is a severe mental disorder characterized by widespread poor medication adherence, which impacts treatment outcomes and quality of life. In rural China, despite the national Severe Mental Illness Management System, day-to-day adherence monitoring still relies largely on family supervision and self-report, creating gaps in early detection of non-adherence. To assess the preliminary effectiveness, feasibility, and acceptability of an electronic Medication Event Monitoring System (MEMS) pillbox to improve antipsychotic adherence among community-dwelling adults with schizophrenia in rural China. We conducted a two-month pilot randomized wait-list controlled trial in two townships in Yunnan Province. Twenty-eight patients were identified via purposive sampling and then individually randomly assigned (1:1) to either the intervention group (active MEMS pillbox) or the control group (deactivated pillbox for Month 1, then activated for Month 2) via a computer-generated random sequence. The primary outcome was medication adherence, secondary outcomes included symptom severity, functional status, adverse effects and attitudes toward medication. We also conducted rapid qualitative research, analyzed using the Consolidated Framework for Implementation Research (CFIR), to assess feasibility and acceptability. At month 1, the intervention group showed higher daily and dose adherence rates than the control group, although these differences did not reach statistically significant. In contrast, self-reported adherence (measured by BARS) and medication attitudes (measured by DAI-10) showed significant improvements over time in both groups. No serious adverse events, psychiatric rehospitalizations, or clinical relapses occurred in either group during the study. Qualitative findings showed high technical acceptance but revealed declining provider motivation over time and systemic performance appraisal pressures as key implementation barriers. This pilot study provides preliminary evidence of the technical feasibility of MEMS for schizophrenia care in rural area; however, given the limited sample size, the findings should be viewed as hypothesis-generating rather than confirmatory. While technically feasible, the broader applicability of MEMS is constrained by organizational and systemic barriers. Future larger-scale trials with extended follow-up are necessary to evaluate long-term sustainability and scalability. Chinese Clinical Trial Registry, ChiCTR2500102022. Retrospectively registered on 7 May 2025. Patients, family caregivers, and village doctors contributed through post-trial qualitative interviews that informed interpretation and refinement; they were not involved in the initial study design or manuscript drafting.