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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-07-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Medication Adherence Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Nominal Financial Incentives

Intervention Type OTHER

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

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Daily Adherence Reminders/Adherence Performance Feedback

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes