Medication nonadherence remains difficult to measure objectively in psychiatric care. This completed, single-center exploratory randomized trial evaluated whether four weeks of AI-enabled smartwatch medication monitoring improved clinician-rated medication adherence compared with waitlist usual care in psychiatric outpatients aged 12 years or older, predominantly adolescents and young adults with mood disorders.
This was a single-center, prospective, exploratory randomized controlled trial conducted in an outpatient psychiatric clinic. Participants aged 12 years or older were randomized 1:1 to an AI-enabled smartwatch medication-monitoring system or waitlist usual care for four weeks. Participants in both groups continued their usual psychiatric care, and no additional medication-adherence counseling was provided as part of the intervention. Medication adherence was assessed at baseline and at Week 4 using the clinician-rated Korean Brief Adherence Rating Scale (K-BARS). The primary analysis compared the change in K-BARS score between the randomized groups. Control participants were offered the smartwatch for an additional four weeks after completing the randomized comparison period. Analyses of responder thresholds, device engagement, and the optional post-waitlist smartwatch period were exploratory. The study was registered retrospectively after enrollment and study completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
85
The smartwatch was designed to detect medication-taking behavior using a built-in camera and electronic tags attached to medication containers. The camera remained inactive under ordinary conditions and captured a brief sequence only when container motion, ambient light, and close proximity between the watch and tag were detected concurrently. The captured sequence was processed by an artificial intelligence algorithm to classify whether a medication-taking event had occurred. Participants assigned to the intervention were instructed to wear the device for four weeks. The device provided monitoring only and delivered no reminders, alerts, counseling, or treatment recommendations.
Wonkwang University Hospital
Iksan, Jeollabuk-do, South Korea
Mean Change From Baseline in Korean Brief Adherence Rating Scale Score at Week 4
Medication adherence was assessed using the clinician-rated Korean Brief Adherence Rating Scale (K-BARS). The clinician assessed the number of prescribed doses, the number of doses reportedly taken, and the frequency of missed doses over the preceding 28 days and integrated this information into a score ranging from 0% to 100%, with higher scores indicating greater medication adherence. For each participant, the change score was calculated as the Week 4 score minus the baseline score. The primary outcome was the difference in mean change score between the randomized groups.
Time frame: Baseline and Week 4
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