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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-enabled smartwatch | Experimental |
| |
| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-enabled smartwatch | Device | 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. |
| 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) |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonkwang University Hospital | Iksan | Jeollabuk-do | 54538 | South Korea |
Irb review is required because data sharing is not mentioned in the agreement
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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This was an exploratory randomized controlled trial. Participants were randomized 1:1 to the AI-enabled smartwatch intervention or usual care for 4 weeks. At the baseline visit, intervention-arm participants received device training and electronic tags were affixed to all active medication containers. Adherence was quantified over two prespecified 28-day windows: a baseline window immediately prior to randomization and a post-intervention window ending at the post-visit. Participants in both arms continued usual psychiatric care; no additional adherence counseling beyond routine practice was provided. Control-arm participants were subsequently offered the smartwatch intervention for an additional 4 weeks following the observation period, forming a within-subject waitlist crossover cohort for exploratory replication analyses.
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The BARS outcome assessor was blinded to treatment allocation at the time of rating; ratings were based on structured interview and pill-count inputs without access to device-recorded data. Participant blinding was not feasible because the intervention consisted of a visible wearable device.
|
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) |
| 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) |
| D001519 | Behavior |