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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907410
• Other study ID #: 18-015434
• Secondary ID: 1K23HL136842-01A
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: July 17, 2022

Study information

• Verified date: March 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 17, 2022
• Est. primary completion date: July 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Medication Adherence

Intervention

Other:
• Nominal Financial Incentives
The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
• Daily Adherence Reminders/Adherence Performance Feedback
Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)	Calculated as the mean daily proportion of prescribed doses taken by study month by study arm. Days that reflect >1 were truncated to 1.	6 months
Secondary	Adherence Trajectory	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.	6 months
Secondary	Changes in Child Asthma Control Tool (cACT) Score	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.	months 2, 4,7, 12
Secondary	Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses	Calculate and compare the number of asthma-related emergency room visits, hospitalizations and oral steroid courses between study arms.	12 months
Secondary	Healthcare Costs of Utilization	Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms.	12 months