to Improve Compliance, Safety
Study funded by National Institute for Child Health and Human Development, 5R43HD047494 Vesta Brue, Principal Investigator
Development and testing of a child-friendly medication reminder and monitoring device
The project aimed to design, build and test a child-friendly medication delivery system that would increase adherence among chronically ill children and their families. A secondary aim was to reduce social stigmas associated with medications.
Eighty-five children with chronic disease were recruited in San Antonio, Texas, through community-based clinics. Ages ranged from 6 to 17 years, with a mean of 11.6 years. Median family income was $45,410. Minority representation was 35% African American and 38% Hispanic. Primary diagnoses were asthma (32.9%) and ADHD (28.2%).
A handheld, wireless, electronic device was developed, backed by a styrene pouch to hold syringes, vials, glucometers, pills or inhalers. Alarms signaled children and parents when doses were scheduled. Sensors recorded pouch openings and time-stamped events. Instantly, the device wirelessly uploaded data to servers, where remote caregivers could view meds-usage charts online. Following a 21-day, randomized and controlled trial, evaluation methods included both qualitative and quantitative measures of product feasibility and reliability. Usability surveys captured user satisfaction.
Overall medication adherence and timing compliance with dosing instructions were primary measures of efficacy. We compared 85 subjects, diagnosed with chronic conditions, in two conditions: (1) using the fully functioning KidSignals™ system with med-time alerts, instant wireless communications uploading to servers, and (2) using masked KidSignals devices that incorporated only time-stamping of pouch openings (comparable monitoring without rendering interventions).
The study combined structured interviews and questionnaires of both children and parents, using an 11-item usability questionnaire and Likert scale. Adherence measures were calculated based upon the number of lid openings that occurred within a 15% optimal dosing time window. Independent groups t-test measured differences in compliance between the active and control groups.
Automated medication reminders showed a clear advantage
The results showed a clear benefit for active signaling over the silent condition. Overall, mean timing compliance in the active group was 70.8% compared to 46.5% in the control condition (t(75)=4.28,p<.0001). The overall result was mirrored for once-a-day dosing: 69.1% vs. 39.2% (t(60)=4.28,p<.0001); twice-daily compliance was 47.7% vs. 16.7%, respectively (t(28)=3.64,p<.002). On overall usability, participants rated KidSignals favorably (3.71 mean out of 5.0, with 5 representing most positive.) Highest-rated features were: device was easy to use (4.61 mean), I would recommend KidSignals to others (4.62 mean) and device helped me remember to take medications (4.56).
Outcomes revealed that reminder functions correlated significantly with better adherence. Caregivers particularly benefited by dosing alerts. In performance tests, KidSignals’ alpha prototypes exceeded expectations for real-time, wireless uploading of medication histories. Similarly, likeability and usability scores were higher than anticipated, suggesting the technology conferred enhanced social status. Open-ended responses supported an encouraging de-stigmatization effect. Children preferred eye-popping, neon colors, in contrast to the device’s discrete styling. Disappointing, however, was willingness to purchase the $150 device, representing lowest favorable response item; most of these low-SES respondents would require subsidy. Few participants had Internet access, which diminished the system’s utility and feedback capabilities, resulting in sub-par ratings for the system’s health-tracking charts. Modifications were suggested, and further testing is indicated. Overall, KidSignals’ alpha tests showed promise for high adoption and use among pediatric populations and caregivers, significant improvement in adherence when fully functioning, and benefits to peace of mind for remote caregivers.