Improving adherence to inhaled corticosteroids (ICS) medication in urban minority pediatric populations is a clinical and population health priority. Financial incentives have been shown as a compelling method to engage a high-risk asthma population in regular ICS use, but whether and how adherence can be maintained and lead to sustained high adherence trajectories is unknown.
Investigators propose to initially enroll 125 children into an initial 1-month run-in interval. Participants who successfully complete the run-in interval will be randomized into a six-month intervention with a six month follow-up period. Children will be ages 5-12, and must have two or more visits to any combination of the outpatient, Emergency Department (ED) or hospital setting in the past year for asthma exacerbations at Children's Hospital of Philadelphia (CHOP). The study intervention will include daily automated medication reminders (either via text message or push reminder), an app to track daily medication use, and nominal incentives to promote daily controller use. Inhaled controller medication adherence and rescue medication use will be measured using electronic monitors affixed to the inhalers. Factors associated with differential adherence will be assessed using surveys administered during enrollment, the experiment interval (months 1 through 3), the observation interval (months 4 through 6), and study completion (months 12-13). Efficacy outcomes will include change in parent-reported asthma control and mean adherence to ICS between study arms during the experiment interval, as well as the observation interval. Patients will be considered fully enrolled when they fulfill the requirements of the Run-in period (sensor data uploaded to research platform AND text message receipt confirmed by caregiver) and are subsequently randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
125
The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Calculated as the mean daily proportion of prescribed doses taken by study month by study arm. Days that reflect \>1 were truncated to 1.
Time frame: 6 months
Adherence Trajectory
Group-based trajectory modeling derived of adherence patterns - not reported by study arm. This secondary outcome was included in the event that there was no difference in adherence between study arms to help identify participant characteristics that were associated with different adherence patterns. The unit of measure is the percentage of participants that fall into each adherence category (low, medium, and high adherence) over a 6-month time period.
Time frame: 6 months
Changes in Child Asthma Control Tool (cACT) Score
Assess the change in total cACT score or parental portion of the cACT from baseline to the second, third, fourth, and fifth study visits. The Child Asthma Control Tool (cACT) score ranges from 0 (poor control) to 27 (complete control) and was assessed at study visits 1 and 3 only. The parental portion of the cACT ranges from 0-15 and was assessed at all study visits. The greater the value, the better the control. The larger the difference (larger magnitude) of the value in the differences between the scores, the greater the improvement in controlling the child's asthma diagnosis.
Time frame: months 2, 4,7, 12
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
Calculate and compare the number of asthma-related emergency room visits, hospitalizations and oral steroid courses between study arms.
Time frame: 12 months
Healthcare Costs of Utilization
Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms.
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Time frame: 12 months