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

Clinical Trial ID: NCT03907410

Description

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 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 be hospitalized or recently hospitalized for asthma 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.


Criteria

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., smartphone) - Prescribed inhaled corticosteroid or corticosteroid/long acting beta agonist combination for daily use - At least 2 hospitalizations OR one hospitalization AND at least one emergency department (ED) visit for asthma in the preceding year - 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.

  • Start Date

    2019-09-01

  • Last Updated

    2020-02-20

  • Sponsor

    National Heart, Lung, and Blood Institute (NHLBI)

  • Condition Name

    Asthma in Children

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