The Study is Enrolling Kids From 7 to 16 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 11/10/2018 |
| Start Date: | March 1, 2018 |
| End Date: | May 2022 |
| Contact: | Tregony Simoneau, MD |
| Email: | tsimoneau@connecticutchildrens.org |
| Phone: | (860) 545-9440 |
A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback
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.
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.
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.
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.
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
We found this trial at
1
site
282 Washington St
Hartford, Connecticut 06106
Hartford, Connecticut 06106
(860) 545-9000
Phone: 860-545-9440
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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