N/A
N=106
The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
Medication Adherence · Asthma in Children
Bottom Line
View on ClinicalTrials.gov: NCT03907410 ↗Enrolled (actual)
106
Serious AEs
16.2%
Results posted
Mar 2024
Primary outcome: Primary: Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) — 0.56; 0.50; 0.52; 0.61 proportion of prescribed doses taken
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nominal Financial Incentives (Other); Daily Adherence Reminders/Adherence Performance Feedback (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) |
0.56; 0.50; 0.52; 0.61; 0.48; 0.47 | — |
| SECONDARY Adherence Trajectory |
20.2; 41.5; 38.2 | — |
| SECONDARY Changes in Child Asthma Control Tool (cACT) Score |
1.73; 2.86; 2.16; 2.19; 3.63; 1.85 | — |
| SECONDARY Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses |
32; 17; 34; 5; 3; 5 | — |
| SECONDARY Healthcare Costs of Utilization |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03907410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.