The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial

Not Applicable

Completed

Conditions: Medication Adherence
Asthma in Children

Interventions: Other: Daily Adherence Reminders/Adherence Performance Feedback
Other: Nominal Financial Incentives

Registration Number: NCT03907410

Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 125

Inclusion Criteria

Males or females age 5 to 12 years and their parent or legal guardian.
Caregiver has an app enabled cellular phone (i.e., smart phone)
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 smart phone 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Reminders & feedback ONLY	Daily Adherence Reminders/Adherence Performance Feedback	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.
Arm 1: Incentives, plus reminders & feedback (IRF)	Daily Adherence Reminders/Adherence Performance Feedback	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.
Arm 1: Incentives, plus reminders & feedback (IRF)	Nominal Financial Incentives	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.

Primary Outcome Measures

Name	Time	Method
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)	6 months	Calculated as the mean daily proportion of prescribed doses taken by study month by study arm. Days that reflect \>1 were truncated to 1.

Secondary Outcome Measures

Name	Time	Method
Changes in Child Asthma Control Tool (cACT) Score	months 2, 4,7, 12	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.
Adherence Trajectory	6 months	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.
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses	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	12 months	Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms.