Clinical trial NCT03907410: The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
Official title: The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Asthma in Children
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-04-09
Enrollment: 125
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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., 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.

Primary outcomes:
measure: Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
timeFrame: 6 months
Secondary outcomes:
measure: Adherence Trajectory
timeFrame: 6 months
measure: Changes in Child Asthma Control Tool (cACT) Score
timeFrame: months 2, 4,7, 12
measure: Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
timeFrame: 12 months
measure: Healthcare Costs of Utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Chen Kenyon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
citation: Henderson BR, Flaherty CM, Floyd GC, You J, Xiao R, Bryant-Stephens TC, Miller VA, Feudtner C, Kenyon CC. Tailored Medication Adherence Incentives Using mHealth for Children With High-Risk Asthma (TAICAM): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 17;9(8):e16711. doi: 10.2196/16711.