Medication AdherenceNCT03907410

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

A study testing Nominal Financial Incentives and Daily Adherence Reminders/Adherence Performance Feedback in people with Medication Adherence and Asthma in Children, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 5 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Medication Adherence, Asthma in Children
What is being tested?: Nominal Financial Incentives and Daily Adherence Reminders/Adherence Performance Feedback
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2019to 17 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Read the 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.

Conditions: Medication Adherence, Asthma in Children
Being tested: Nominal Financial Incentives, Daily Adherence Reminders/Adherence Performance Feedback
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nominal Financial IncentivesOther
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 FeedbackOther
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.

Study groups in NCT03907410
Study group	Role	What they receive
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. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 12 months
Healthcare Costs of Utilization
Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201917 Jul 2022

First posted9 Apr 2019
Study start1 Sep 2019
Primary completion17 Jul 2022
Study completion17 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Medication AdherenceStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03907410
Sponsor's protocol ID: 18-015434
Other IDs: 1K23HL136842-01A1
Status last verified: Mar 2024
First submitted: 5 Apr 2019
Last updated: 18 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40094638
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.
PubMed 35691614
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.
PubMed 32459653

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
ClinicalTrials.gov ID: NCT03907410
Acronym / sponsor ID: 18-015434
Conditions: Medication Adherence, Asthma in Children
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Study start: 1 Sep 2019 (actual)
Primary completion: 17 Jul 2022 (actual)
Study completion: 17 Jul 2022 (actual)
First posted: 9 Apr 2019 (actual)
Results: Posted 18 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Arm 1: Incentives, plus reminders & feedback (IRF)	Experimental	Other: Nominal Financial Incentives, Other: Daily Adherence Reminders/Adherence Performance FeedbackThere 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.
Arm 2: Reminders & feedback ONLY	Active comparator	Other: Daily Adherence Reminders/Adherence Performance FeedbackThere 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.
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.

Who may qualify

Ages: 5 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nominal Financial IncentivesThe 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	Arm 1: Incentives, plus reminders & feedback (IRF)
Daily Adherence Reminders/Adherence Performance FeedbackStudy 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.	Other	Arm 1: Incentives, plus reminders & feedback (IRF), Arm 2: Reminders & feedback ONLY

Primary outcome

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.

4 secondary outcomes

Adherence Trajectory
Time frame: 6 months
Changes in Child Asthma Control Tool (cACT) Score
Time frame: months 2, 4,7, 12
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
Time frame: 12 months
Healthcare Costs of Utilization
Time frame: 12 months

Results and safety

Results posted to the registry on 18 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Incentives, Plus Reminders & Feedback (IRF)	42	38
Arm 2: Reminders & Feedback ONLY	22	21
Arm 3 (Control)	42	40

Primary outcome: Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)

Time frame: 6 months. Mean (95% Confidence Interval). Unit: proportion of prescribed doses taken

Measure	Arm 1 n = 38	Arm 2 n = 21	Arm 3 n = 40
Month 0	0.56 (0.52 to 0.61)	0.50 (0.44 to 0.57)	0.52 (0.47 to 0.57)
Month 1	0.61 (0.57 to 0.66)	0.48 (0.41 to 0.54)	0.47 (0.41 to 0.52)
Month 2	0.56 (0.52 to 0.61)	0.45 (0.38 to 0.51)	0.38 (0.33 to 0.43)
Month 3	0.55 (0.49 to 0.60)	0.44 (0.37 to 0.51)	0.39 (0.34 to 0.45)
Month 4	0.44 (0.39 to 0.48)	0.40 (0.32 to 0.47)	0.45 (0.39 to 0.50)
Month 5	0.35 (0.29 to 0.40)	0.30 (0.23 to 0.37)	0.41 (0.35 to 0.46)
Month 6	0.38 (0.34 to 0.42)	0.34 (0.28 to 0.40)	0.48 (0.43 to 0.53)

Arm 1 vs Arm 3: Mean Difference (Final Values): 15 (95% CI 2 to 28)
Arm 1 vs Arm 3: Mean Difference (Final Values): -6 (95% CI -20 to 7)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the entirety of the participant's study period (12 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Incentives, Plus Reminders & Feedback (IRF)	6 of 38 (15.8%)	17 of 38 (44.7%)	0 of 38
Arm 2: Reminders & Feedback ONLY	4 of 21 (19%)	13 of 21 (61.9%)	0 of 21
Arm 3 (Control)	6 of 40 (15%)	22 of 40 (55%)	0 of 40

Limitations and caveats (from the sponsor): (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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40094638Kenyon 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.
Derived from this study: PubMed 35691614Chan 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.
Derived from this study: PubMed 32459653Henderson 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chen Kenyon, MD principal investigator

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03907410, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.