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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Health Services Research
- Masking: Double (Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 30, 2022
Investigators propose to enroll 125 children and their parents in 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, 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 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.
- Other: Nominal Financial Incentives
- 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.
- Other: Daily Adherence Reminders/Adherence Performance Feedback
- 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.
Arms, Groups and Cohorts
- Experimental: Arm 1: Incentives, plus reminders & feedback (IRF)
- There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0). During the “Experiment” period (Months 1-3), Arm 1 will receive the IRF intervention. During the “Observation” period (Months 4-6), all the arms will have continued daily ICS monitoring to assess enduring effects of each arm – no IRF.
- Active Comparator: Arm 2: Reminders & feedback ONLY
- There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0). During the “Experiment” period (Months 1-3), Arm 2 will receive ONLY reminders and feedback, without nominal financial incentives. During the “Observation” period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm – no IRF.
- No Intervention: Arm 3 (Control)
- There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0). During the “Experiment” period (Months 1-3), Arm 3 will not receive any component of the IRF intervention. During the “Observation” period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm – no IRF.
Clinical Trial Outcome Measures
- Adherence to ICS regime
- Time Frame: 6 months
- Calculated as the mean daily proportion of prescribed doses taken by study month. Days that reflect >1 will be truncated to 1.
- Adherence trajectory
- Time Frame: 6 months
- Calculate group-based modeling of adherence patterns
- Changes in Child Asthma Control Tool (cACT) score
- Time Frame: 12 months
- Assess the cACT score at multiple time points and evaluate the changes in score from first study visit 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). The greater the value, the higher 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.
- Number of asthma-related emergency room visits, hospitalizations and oral steroid courses
- Time Frame: 12 months
- Calculate and compare the number of asthma-related emergency room visits, hospitalizations and oral steroid courses between study arms.
- Healthcare costs of utilization
- Time Frame: 12 months
- Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescription between study arms.
Participating in This Clinical Trial
- Males or females age 5 to 12 years and their parent or legal guardian. – Caregiver has an app enabled cellular phone (i.e., smartphone) – Prescribed inhaled corticosteroid or corticosteroid/long acting beta agonist combination for daily use – At least 2 asthma exacerbations in the preceding year (Any combination of hospitalizations, ED visits, or outpatient visits where oral steroid courses were administered for asthma) – Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria:
- Subjects prescribed a controller medication to which the electronic device cannot affix – Subjects in which the mobile app is not compatible with their smartphone model – Subjects with major developmental delays or disabilities – Subjects with comorbid chronic diagnoses that influence their asthma management such as cystic fibrosis, bronchopulmonary dysplasia, or cyanotic heart disease – Families with active Department of Human Services (DHS) involvement – Non-English speaking families – Parents/guardians or subjects whose medical team recommends against approaching for enrollment in a research study.
Gender Eligibility: All
Minimum Age: 5 Years
Maximum Age: 12 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Children’s Hospital of Philadelphia
- National Institutes of Health (NIH)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Chen Kenyon, MD, Principal Investigator, Children’s Hospital of Philadelphia
- Overall Contact(s)
- Chen Kenyon, MD, 267-426-6339, email@example.com
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