Clinical trial NCT03734861: The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
Official title: A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 75
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to one of two arms:

1. BreathSmart system
2. Standard of Care
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Days Covered (PDC)
timeFrame: 6 months post start of intervention
Secondary outcomes:
measure: Asthma Control Test
timeFrame: 6 months post start of intervention
measure: FEV1% Predicted
timeFrame: Baseline to 6 months
measure: Changes in Medication Adherence and Lung Function
timeFrame: Baseline to 6 months post start of intervention
measure: Number of Participants With Visits to ER for Asthma
timeFrame: Baseline to 6 months post start of intervention
measure: Number of Missed Days of School
timeFrame: Last 30 days from baseline visit and last 30 days from 6-month follow-up visit
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Childrens Medical Center
name: Tregony Simoneau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hollenbach J, Simoneau T, Sun Y, Becene I, Almeida S, Langton C, Flores G. Design, methods, and baseline characteristics of a pilot, randomized, controlled trial of the effects of an electronic monitoring device on medication adherence in children with asthma. Contemp Clin Trials Commun. 2021 Feb 6;21:100706. doi: 10.1016/j.conctc.2021.100706. eCollection 2021 Mar.