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

NCT07455916 | Completed DMC

• 1 other identifier: WKUH 2022-11-042
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Disease; Adherence to Care; Digital Health

Keywords

psychiatry; medication adherence; wearable; smartwatch; randomized trial; artificial intelligence; digital therapeutics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Responder Rate at Δ ≥ 10 Percentage Points

  Baseline to end of intervention (4 weeks)

• Responder Rate at Δ ≥ 20 Percentage Points

  Baseline to end of intervention (4 weeks)

Other Outcomes (2)

• Association Between Device Engagement and BARS Change Score

  4 weeks (intervention perio

• Within-Subject Adherence Change in Waitlist Crossover Cohort

  Baseline, end of waitlist observation (week 4), and end of smartwatch period (week 8)

Study Arms (2)

AI-enabled smartwatch

EXPERIMENTAL

Device: AI-enabled smartwatch

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.

Interventions

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.

AI-enabled smartwatch

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwang University Hospital

Iksan, Jeollabuk-do, 54538, South Korea

Location

MeSH Terms

Conditions

Mental Disorders; Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor, department of psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 6, 2026
• Study Start: December 31, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)