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

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence; Asthma in Children
• Intervention / Treatment: Other: Nominal Financial Incentives; Other: Daily Adherence Reminders/Adherence Performance Feedback

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Incentives, plus reminders & feedback (IRF); 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.	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.; Other: 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.
Active Comparator: Arm 2: Reminders & feedback ONLY; 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.	Other: 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.
No Intervention: Arm 3 (Control); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Healthcare Costs of Utilization	Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms.	12 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Chen Kenyon, MD, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): July 17, 2022
• Study Completion (Actual): July 17, 2022

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 18-015434; 1K23HL136842-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No