The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Nominal Financial Incentives (Other)
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.
干预措施: Daily Adherence Reminders/Adherence Performance Feedback (Other)
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.
干预措施: Daily Adherence Reminders/Adherence Performance Feedback (Other)
结局指标
主要结局
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
时间窗: 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.
次要结局
- Changes in Child Asthma Control Tool (cACT) Score(months 2, 4,7, 12)
- Adherence Trajectory(6 months)
- Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses(12 months)
- Healthcare Costs of Utilization(12 months)