AI-Enabled Smartwatch for Medication Adherence in Outpatient Psychiatry

August 20, 2026 updated by: Sung Hoon Yoon, Wonkwang University Hospital

Short-Term Effects of an AI-Enabled Smartwatch on Medication Adherence in Adolescents and Young Adults With Mood Disorders: An Exploratory Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Jeollabuk-do
      • Iksan, Jeollabuk-do, South Korea, 54538
        • Wonkwang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 12 years or older
  • Receiving outpatient psychiatric care at Wonkwang University Hospital
  • Receiving at least one regularly prescribed psychotropic medication
  • Willing and able to wear the study smartwatch and complete the study assessments
  • Able to provide written informed consent; for minors, written assent and written consent from a parent or legal guardian were required

Exclusion Criteria:

  • Diagnosed congenital genetic disorder
  • Clear history of acquired brain injury
  • Seizure disorder or another neurological condition that could interfere with study participation
  • Psychotic symptoms, aggression, or behavioral instability severe enough to prevent safe and stable smartwatch use or create a substantial risk of device damage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-enabled smartwatch
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
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.
No Intervention: Waitlist Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Korean Brief Adherence Rating Scale Score at Week 4
Time Frame: Baseline and 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.
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate at Δ ≥ 10 Percentage Points
Time Frame: Baseline to end of intervention (4 weeks)
Proportion of participants achieving a BARS change score of at least 10 percentage points from baseline. Between-group comparison using logistic regression to estimate odds ratio and 95% confidence interval.
Baseline to end of intervention (4 weeks)
Responder Rate at Δ ≥ 20 Percentage Points
Time Frame: Baseline to end of intervention (4 weeks)
Proportion of participants achieving a BARS change score of at least 20 percentage points from baseline. Between-group comparison using logistic regression to estimate odds ratio and 95% confidence interval.
Baseline to end of intervention (4 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between Device Engagement and BARS Change Score
Time Frame: 4 weeks (intervention perio
Among intervention-arm participants, association between device engagement rate (proportion of intervention days with ≥1 device-recorded medication event) and BARS change score, analyzed using Pearson correlation and linear regression.
4 weeks (intervention perio
Within-Subject Adherence Change in Waitlist Crossover Cohort
Time Frame: Baseline, end of waitlist observation (week 4), and end of smartwatch period (week 8)
Among control-arm participants who subsequently completed the smartwatch period, comparison of adherence measured during the waitlist observation phase versus the subsequent smartwatch period. Paired comparison using t-test.
Baseline, end of waitlist observation (week 4), and end of smartwatch period (week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonkwang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2022

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WKUH 2022-11-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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