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

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Medication Adherence; Asthma in Children

Treatments: Other: Daily Adherence Reminders/Adherence Performance Feedback; Other: Nominal Financial Incentives

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03907410

1K23HL136842-01A1 (U.S. NIH Grant/Contract)

18-015434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 3 patient groups

Arm 1: Incentives, plus reminders & feedback (IRF)

Experimental group

Description:

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.

Treatment:

Other: Daily Adherence Reminders/Adherence Performance Feedback

Other: Nominal Financial Incentives

Arm 2: Reminders & feedback ONLY

Active Comparator group

Description:

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.

Treatment:

Other: Daily Adherence Reminders/Adherence Performance Feedback

Arm 3 (Control)

No Intervention group

Description:

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.