A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Proportion of Days Covered (PDC)
研究概览
简要总结
Non-adherence to controller medication is a common problem in children with Asthma, resulting in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks, and increased emergency room visits and hospital admissions. Additionally, current absence of a gold standard to measure adherence forces clinicians and researchers to rely on patient-self report, which is notoriously inaccurate, to support clinical decision making. Many young patients suffer from both intentional and non-intentional non-adherence, thus an appropriate intervention must address both types. Current studies using electronic monitoring devices (EMDs) primarily focus on non-intentional non-adherence through reminder systems and thus are limited in their ability to engage patients for long-term behavior change.
This trial addresses an important knowledge gap by evaluating whether EMDs with a combination of reminder system and patient education can prove to be effective in increasing adherence rates and can be used in clinical practice to achieve better asthma control and outcomes through improved patient and clinician engagement.
详细描述
This is a prospective, randomized, controlled study of children with persistent asthma who are managed on daily inhaled corticosteroids (ICS). 75 children will be randomized 2:1 into one of two arms:
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50 children will be randomized to BreatheSmart, comprised of:
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BreatheSmart mobile application that tracks medication usage and sends real time reminders
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HeroTracker sensor that counts dosage and monitors real-time medication adherence
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CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)
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25 children will be randomized to "standard of care"(control arm). These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8 to 17
- •Diagnosis of persistent asthma
- •Prescribed an inhaled corticosteroid (ICS) for at least one month prior to enrollment
- •Use of a pressurized metered dose inhaler (pMDI) compatible with the Cohero mHealth Herotracker (See Appendix)
- •Parent/child possess a compatible smartphone (iOS 8.0 or higher)
- •English or Spanish speaking
排除标准
- •Presence of another chronic lung disease or condition such as cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, or presence of tracheostomy
- •Presence of other chronic medical condition such as congenital heart disease or immunodeficiency
- •Presence of other comorbidities that, in the opinion of the investigator, will interfere with collection of study procedures, or limits life expectancy to < 1 year
- •Currently pregnant or planning to become pregnant during the trial period
结局指标
主要结局
Proportion of Days Covered (PDC)
时间窗: 6 months post start of intervention
Medication adherence among children using BreatheSmart with feedback (intervention) compared to control group (standard of care) at 6 months. The primary outcome was medication adherence as measured using pharmacy refill. Medication adherence as measured by pharmacy refills was calculated using proportion of days covered (PDC), a validated method of calculating adherence, defined as a ratio of the sum of unique days supplied based on refills over the total number of days in the assessed period.
次要结局
- Asthma Control Test(6 months post start of intervention)
- FEV1% Predicted(Baseline to 6 months)
- Number of Participants With Visits to ER for Asthma(Baseline to 6 months post start of intervention)
- Number of Missed Days of School(Last 30 days from baseline visit and last 30 days from 6-month follow-up visit)
- Changes in Medication Adherence and Lung Function(Baseline to 6 months post start of intervention)