Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL136842-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chen Kenyon, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40094638 | Derived | 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. | |
| 35691614 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
19 participants did not successfully complete the run-in period and, thus, were not randomized. 106 study participants were randomized in a 2:1:2 schema. The caregiver-child dyad was one unit. If the caregiver withdrew from the study, the child also withdrew from the study. Medication adherence was only collected from the child, but caregivers were included in the dyad-language given that they were interacting with certain parts of the intervention employed.
125 participants were initially enrolled into the 1 month study run-in period, in which they were needed to successfully (1) synchronize their electronic study sensor with the caregivers smartphone (via Bluetooth) and the Way to Health study platform (via wireless or cellular data) and (2) respond to an automated text message from the Way to Health study platform.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The "Sex (Female, Male)" and "Race/Ethnicity, Customized" baseline characteristics for the child were collected from the parent/caregivers involved in the study. These variables were not collected for the parents/caregivers.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | proportion of prescribed doses taken | 6 months |
|
Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma Exacerbation or Increased Asthma Symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma Exacerbation or Increased Asthma Symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
(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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chen Kenyon | Children's Hospital of Philadelphia | 2674266339 | kenyonc@chop.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2023 | Aug 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 19, 2020 | Sep 15, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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 |
| 32459653 | 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. |
| BG001 | 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. 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Run-in Period ICS Adherence | Mean | Standard Deviation | % of doses taken |
|
|
|
|
| Secondary | 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. | The total cohort of 99 participants were analyzed to assign participants to one adherence group based on their adherence to the inhaled corticosteroid medication over the study interval. As pre-specified in the study protocol, this outcome measure represents group-based modeling of adherence patterns agnostic of study arm. | Posted | Number | percentage of study participants | 6 months |
|
|
|
| Secondary | 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. | The number analyzed in the study visits differ as some participants did not complete all study visits. | Posted | Mean | Standard Deviation | score on a scale | months 2, 4,7, 12 |
|
|
|
| Secondary | 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. | The oral steroid course outcome was a secondary outcome added when we expanded inclusion criteria during the Coronavirus pandemic, so it is only reported for a proportion of participants. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Healthcare Costs of Utilization | Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms. | This secondary outcome will not be analyzed because this data was not collected for reasons related to the onset of the COVID-19 pandemic. | Posted | 12 months |
|
|
| 0 |
| 38 |
| 6 |
| 38 |
| 17 |
| 38 |
| EG001 | 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. 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. | 0 | 21 | 4 | 21 | 13 | 21 |
| EG002 | 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. | 0 | 40 | 6 | 40 | 22 | 40 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Risk for Neurologic Deterioration | Nervous system disorders | Systematic Assessment |
|
| Joint/Extremity Pain or Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hordeolum Externum | Infections and infestations | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Otitis Externa | Infections and infestations | Systematic Assessment |
|
| Seizures | Nervous system disorders | Systematic Assessment |
|
| Viral Infection | Infections and infestations | Systematic Assessment |
|
| Concerns for glass ingestion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Flu | Infections and infestations | Systematic Assessment |
|
| Balantitis Xerotica Obliterans | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tooth Pain/Dental Cavities | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D001519 | Behavior |
| Study Visit 3 - Month 4 |
|
|
| Study Visit 4* (only parental portion of ACT collected: Range 0-15) - Month 7 |
|
|
| Study Visit 5* (only parental portion of ACT collected: Range 0-15) - Month 12 |
|
|
| 1 hospitalization |
|
|
| 2 hospitalizations |
|
|
| 3 hospitalizations |
|
|
| 0 emergency department visits |
|
|
| 1 emergency department visit |
|
|
| 2 emergency department visits |
|
|
| 3 emergency department visits |
|
|
| 0 oral steroid courses |
|
|
| 1 oral steroid course |
|
|
| 2 oral steroid courses |
|
|
| 3 oral steroid courses |
|
|
| 4 oral steroid courses |
|
|
| 5 or more oral steroid courses |
|
|