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

NCT07455916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Wonkwang University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07455916 on ClinicalTrials.gov