CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
BreatheSmart System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03734861
NCT03734861N/ACompleted

A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback

Connecticut Children's Medical Center·interventional·Posted Nov 8, 2018·Updated Apr 7, 2023

In Brief

A clinical study evaluating BreatheSmart System and Standard of Care for Asthma. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 8, 2018
Enrollment StartMar 1, 2018
Primary CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.6 years ago

Interventions

BreatheSmart Systemdevice

* BreatheSmart System: a 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 adherence

Standard of Careother

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.