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

NCT03907410 | Completed Results DMC

• 2 other identifiers: 18-0154341K23HL136842-01A1
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Adherence; Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adherence Trajectory

  6 months

• Changes in Child Asthma Control Tool (cACT) Score

  months 2, 4,7, 12

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

  12 months

• Healthcare Costs of Utilization

  12 months

Study Arms (3)

Arm 1: Incentives, plus reminders & feedback (IRF)

EXPERIMENTAL

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; Other: Daily Adherence Reminders/Adherence Performance Feedback

Arm 2: Reminders & feedback ONLY

ACTIVE COMPARATOR

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

Arm 3 (Control)

NO INTERVENTION

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.

Interventions

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.

Arm 1: Incentives, plus reminders & feedback (IRF)

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.

Arm 1: Incentives, plus reminders & feedback (IRF); Arm 2: Reminders & feedback ONLY

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Kenyon CC, Quarshie WO, Xiao R, Yazdani M, Flaherty CM, Floyd GC, Miller VA, Bryant-Stephens TC, Zorc JJ, Feudtner C. Tailored Adherence Incentives for Childhood Asthma Medications: A Randomized Clinical Trial. JAMA Pediatr. 2025 May 1;179(5):500-507. doi: 10.1001/jamapediatrics.2025.0010.

  PMID: 40094638 DERIVED

• 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.

  PMID: 35691614 DERIVED

• 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.

  PMID: 32459653 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

(1) The study included no "real world" control comparison group. Active control received electronic inhaler sensors with linked smartphone application which tracked medication usage and notified participants when usage changed. (2) The study had a relatively small sample size, though sufficiently powered to detect a difference between arm 1 (IRF) and arm 3 (active control). (3) The child portion of the Child Asthma Control Test (cACT, secondary outcome) was not completed at each study visit.

Results Point of Contact

• Title: Chen Kenyon
• Organization: Children's Hospital of Philadelphia

kenyonc@chop.edu

2674266339

Study Officials

• Chen Kenyon, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: September 1, 2019
• Primary Completion: July 17, 2022
• Study Completion: July 17, 2022
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)