Short-Term Effects of an AI-Based Wearable Adherence Monitor in Outpatient Psychiatry

Short-Term Effects of an AI-Based Wearable Adherence Monitor in Outpatient Psychiatry: Randomized Controlled Trial.

Medication nonadherence undermines treatment effectiveness in psychiatric care, yet objective measurement in routine practice remains challenging. AI-enabled wearables may offer scalable monitoring, but evidence from randomized evaluations is limited. This exploratory trial evaluated the short-term effect of an AI-enabled smartwatch intervention on clinician-assessed medication adherence in adolescent and young adult psychiatric outpatients.

Study Overview

• Status: Completed
• Conditions: Mental Disease; Adherence to Care; Digital Health
• Intervention / Treatment: Device: AI-enabled smartwatch

Detailed Description

We conducted a single-center, prospective, exploratory randomized controlled trial of an AI-enabled smartwatch adherence-monitoring system in outpatient psychiatric care. Participants aged ≥12 years were randomized 1:1 to smartwatch intervention or usual care for 4 weeks. The primary outcome was the between-group difference in change in Brief Adherence Rating Scale (BARS) score (Δ = post - pre) over prespecified 28-day baseline and post-intervention windows. The BARS is a clinician-administered instrument that incorporates pill-count components (prescribed count, actual count taken, missed-dose frequency) integrated into a 0-100% visual analog score. Prespecified secondary analyses included responder thresholds at Δ ≥10 and ≥20 percentage points. Exploratory analyses examined the association between device engagement and BARS change score, and a within-subject comparison in waitlist participants who subsequently completed the smartwatch period. Analyses used complete cases with linear regression (adjusting for baseline adherence, age, and sex) and HC3 robust standard errors; ANCOVA served as a confirmatory model. Pre-specified sensitivity analyses included bootstrap resampling, Winsorized regression, and Wilcoxon rank-sum testing. Because of the exploratory/feasibility design, the a priori sample size calculation used α = 0.20; all inferential analyses were reported at two-sided α = 0.05.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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 the Department of Psychiatry
• Willing to wear a study smartwatch and undergo study assessments
• Able to provide written informed consent (or assent with parental consent for minors)

Exclusion Criteria:

• Age under 12 years
• Diagnosed with congenital genetic disorders
• Clear history of acquired brain injury (e.g., cerebral palsy, cerebral infarction)
• Comorbid seizure disorders or other neurological conditions
• Severe psychotic symptoms or aggression precluding safe and stable smartwatch use or posing risk of device damage

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-enabled smartwatch	Device: AI-enabled smartwatch; The device was designed to monitor medication-related behaviors in real-world settings (pill taking and, by design, use of eye drops, inhalers, and nasal sprays). A built-in camera remained in sleep mode and recorded brief ~20-second clips only when an electronic tag affixed to the medication container signaled three concurrent conditions: (1) container motion detected by the tag's accelerometer, (2) ambient light detected by the tag's light sensor, and (3) watch-tag proximity within approximately 10-15 cm via BLE ranging. After capturing a clip, the camera returned to sleep. Encrypted videos were transmitted to a secure server and linked to de-identified study IDs. Server-side algorithms then analyzed the full 20-second sequence, covering the continuous hand actions from opening to closing of the container, and returned a binary medication event (medication vs no medication). Participants were instructed to wear the smartwatch for 4 weeks.
No Intervention: Control group; Participants in the control arm received usual psychiatric care for 4 weeks without the smartwatch intervention. After completing the observation period, control participants were offered the smartwatch intervention for an additional 4 weeks, forming a within-subject waitlist crossover cohort used for exploratory replication analyses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brief Adherence Rating Scale (BARS) Score	Medication adherence was assessed using the Brief Adherence Rating Scale (BARS), a clinician-administered instrument that structurally incorporates pill-count components (Byerly et al., 2008). At each assessment, the clinician elicits the number of pills prescribed over the preceding 28 days, the number actually taken, and the frequency of missed doses, and integrates these inputs with the structured patient interview into a 0-100% visual analog score. The primary outcome is the between-group difference in BARS change score (Δ = post - pre).	Baseline (pre-randomization 28-day window) and end of intervention (28-day post-intervention window, week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate at Δ ≥ 10 Percentage Points	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	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	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	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

• Sponsor: Wonkwang University Hospital

Study record dates

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): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: randomized trial; wearable; artificial intelligence; medication adherence; psychiatry; smartwatch; digital therapeutics
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Mental Disorders; Medication Adherence
• 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: Irb review is required because data sharing is not mentioned in the agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No