An interventional study of AI-enabled smartwatch in Mood Disorders, Medication Adherence and Mental Disorders, sponsored by Wonkwang University Hospital. Completed at 1 site in South Korea. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Wonkwang University Hospital · Not applicable, Interventional, and Treatment
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.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's enrollment of 85 is close to the median of 80 across 419 interventional studies indexed under Mood Disorders.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants continued their usual psychiatric care and wore the AI-enabled smartwatch medication-monitoring system for four weeks. Electronic tags were attached to their active medication containers. The device did not provide medication reminders, adherence feedback, or additional counseling, and device-derived data were not returned to the treating clinician during the randomized comparison period.
Device: AI-enabled smartwatch
Participants continued usual psychiatric care for four weeks without smartwatch monitoring or additional medication-adherence counseling. After completing the randomized comparison period, participants were offered optional use of the smartwatch for an additional four weeks. Data from this optional period were analyzed exploratorily.
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.
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
Plan to share: No — Individual participant data will not be shared because the participant consent documents did not include public or external sharing of de-identified individual-level data. Any future data sharing would require additional review and approval by the Institutional Review Board.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Wonkwang University Hospital