N/A
Completed N=75
The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
Source: ClinicalTrials.gov NCT03734861 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Proportion of Days Covered (PDC) — 0.39; 0.33 proportion of days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Days Covered (PDC) |
0.39; 0.33 | — |
| SECONDARY Asthma Control Test |
18.9; 17.9; 21.2; 20; 19.7; 17.9 | — |
| SECONDARY FEV1% Predicted |
89.7; 92.4; 86.5; 99.7; 90.5; 103.6 | — |
| SECONDARY Changes in Medication Adherence and Lung Function |
0.221; 0.283; -0.081; 0.174 | — |
| SECONDARY Number of Participants With Visits to ER for Asthma |
0; 1; 3; 3 | — |
| SECONDARY Number of Missed Days of School |
1.12; 1.04; 2.1; 3.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT03734861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.