Enhancing medication safety engagement among older adults with diabetes and comorbidities: a quasi-experimental study...

Medication-related issues are prevalent among older adults with chronic diseases, especially in community outpatient settings where medication regimens are complex and largely self-managed. These issues, such as inappropriate prescribing, non-adherence and drug interactions, can result in avoidable harm and increased healthcare burden. Although patient engagement is crucial for medication safety, few interventions are based on behavioural theory or tailored for older adults in low-resource settings. Digital health tools present promising opportunities to provide personalised, accessible medication safety support. This study aims to develop, implement and evaluate a theory-informed digital intervention to enhance medication safety engagement among older adults with chronic conditions in community settings.

This quasi-experimental study will take place in two community health service centres in Beijing, China. Participants will be older adults aged 60-80 years with type 2 diabetes and at least one additional chronic condition. They must be prescribed at least one antidiabetic medication, capable of using a smartphone, cognitively intact and permanent residents of Beijing. The study plans to recruit 388 participants (194 per arm) to achieve 80% power with a two-sided α=0.05. Participants will be assigned to either an intervention group receiving a digital medication safety programme or a control group receiving routine care and printed educational materials. The intervention is a structured, theory-informed programme delivered via a WeChat-based platform, aimed at enhancing medication safety engagement among older adults. The study follow-up will last 3 months. The primary outcome is the change in medication safety engagement, measured using a validated scale. Secondary outcomes include perceived efficacy in patient-physician interactions, medication knowledge and fasting glucose levels. The acceptability of the intervention will be evaluated in the intervention group using the System Usability Scale and qualitative interviews. Data collection will occur at baseline, 1 month and 2 months post-intervention.

Ethical approval was obtained from the Medical Ethics Committee of Capital Medical University, Beijing, China (initial approval Z2023SY066 on May 2023; amendment Z2025SY020 on April 2025). All participants will provide written informed consent prior to enrolment. The study findings will be disseminated through peer-reviewed publications and conference presentations. A model participant information sheet and informed consent form has been developed for this trial.

Chinese Clinical Trial Registry (ChiCTR2300072716).