The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.

Connecticut Children's Medical Center

Status: Completed

Conditions: Asthma

Treatments: Other: Standard of Care; Device: BreatheSmart System

Study type: Interventional

Funder types: Other

Identifiers

NCT03734861

17-043

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

BreatheSmart System

Experimental group

Description:

* 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)

Treatment:

Device: BreatheSmart System

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard of Care