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Completed

NCT Number: NCT03907410

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nominal Financial Incentives

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

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.

Primary outcomes

  1. Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)

    Time frame: 6 months

    Calculated as the mean daily proportion of prescribed doses taken by study month by study arm. Days that reflect >1 were truncated to 1.

Secondary outcomes

  1. Adherence Trajectory

    Time frame: 6 months

    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.

  2. Changes in Child Asthma Control Tool (cACT) Score

    Time frame: months 2, 4,7, 12

    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.

  3. Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses

    Time frame: 12 months

    Calculate and compare the number of asthma-related emergency room visits, hospitalizations and oral steroid courses between study arms.

  4. Healthcare Costs of Utilization

    Time frame: 12 months

    Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2019
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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