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Completed
NCT03648450
Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma
Conditions: Asthma
Sex: All
Ages: 4 Years – 18 Years
Healthy volunteers: No
Enrollment: 42
Sponsor: Connecticut Children's Medical Center
Location: Connecticut Children's Medical Center Hartford Connecticut
Summary
The main hypothesis of this study is to see if children and adolescents with poorly controlled asthma will find the Propeller electronic monitoring device is feasible and acceptable, and will result in improved medication adherence and asthma control. Preliminary studies indicate that Propeller can improve medication adherence rates in children with asthma and reduce the number of days of reliever medication used. It also has been shown to reduce missed days of school and hospitalizations due to asthma exacerbations. The Propeller device is a sensor that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication. It also records use of the controller and rescue inhalers, allowing for parents, physicians, and patients to get a fuller and more accurate picture of their adherence to treatment and severity of disease. With improved adherence, asthma control should improve, resulting in a decreased costs and use of services.
Eligibility Criteria
Inclusion Criteria:
1. Children in the ED or inpatient setting presenting with an asthma exacerbation between 4-18 years old
2. History of persistent asthma (defined as prescribed a controller medication)
3. Both the child and primary caregiver/parent have access to a cell phone with an activated number
4. Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Child or parent has no access to a personal cell phone.
2. The child has another chronic pulmonary condition (for example, cystic fibrosis)
3. Having any chronic condition that could affect the child's ability to participate in the study (examples: cancer, autism, or cerebral palsy)
4. The subject has an inhaler medication besides the following, given these are the current medications compatible with the Propeller EMD.
i. Advair HFA ii. Flovent HFA iii. QVAR HFA v. Ventolin HFA vi. ProAir HFA
Source: ClinicalTrials.gov (NCT03648450). StuddyBuddy aggregates publicly available trial information.