Connecticut Children's Medical Center
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.
Asthma
BreatheSmart System
Standard of Care
Not Applicable
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: 50 children will be randomized to BreatheSmart, comprised of: BreatheSmart mobile application that tracks medication usage and sends real time reminders HeroTracker sensor that counts dosage and monitors real-time medication adherence CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm) 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.
| Study Type : | Interventional |
| Estimated Enrollment : | 75 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback |
| Actual Study Start Date : | March 1, 2018 |
| Estimated Primary Completion Date : | August 31, 2020 |
| Estimated Study Completion Date : | August 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BreatheSmart System BreatheSmart mobile application that tracks medication usage and sends real time reminders HeroTracker sensor that counts dosage and monitors real-time medication adherence CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm) |
Device: BreatheSmart System |
|
Active Comparator: Standard of Care 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. |
Other: Standard of Care |
| Ages Eligible for Study: | 8 Years to 17 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106