Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
NCT Number: NCT03648450
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.
Looking for future studies?
Notify Me10 year–18 year
All sexes
Observational
Hartford, Connecticut, 06106, United States
This study is a prospective cohort study using a pre-/post-design.
The target population consists of children and adolescents 10-18 years old making an ED visit or admitted to the hospital at Connecticut Children's Medical Center for an asthma exacerbation.
All patients will receive two Propeller devices (for controller and rescue inhalers), an App for their smartphone, and a free Propeller subscription, which provides access support and services, and hardware and software updates. Only the children and adolescents involved with the study will have the app on their phone. The parents will not put the Propeller app on their phone. Families will be asked to share the study information with their primary care provider and will be provided with an introductory letter to bring to the provider, if they so choose.
Data collection will begin at enrollment and will continue through the three-month follow-up period. Propeller provides the option of continuous monitoring and data collection beyond study cessation.
Data uploads to the portal occur automatically for patients and caregivers who have installed the Propeller App on their smartphone. Additionally, patients' primary-care providers will receive a password allowing them to track and access participants' dashboard. Patients will bring a letter to their primary-care provider explaining that they are part of a study of Propeller's device, and receive instructions on how to view the dashboard and adherence data.
At enrollment, participants and parents will complete the Test of Adherence to Inhalers (TAI), Asthma Control Test (ACT) and PedsQL, along with providing baseline medical history/asthma history data and sociodemographic. The TAI, ACT and PedsQL surveys will again be completed one and three months post enrollment information. Additionally, participants will answer an adapted AMDAT survey that will be used to provide acceptability data about the Propeller device.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
i. Advair HFA ii. Flovent HFA iii. QVAR HFA v. Ventolin HFA vi. ProAir HFA
Propeller electronic monitoring device is a sensor that fits on top of inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication.
Time frame: The information will be collected at three months
This will be assessed by recording the number and percentage of the children and adolescents still using Propeller at three months.
Time frame: Data will be captured at enrollment, one month and three months after enrollment
Acceptability will be determined by phone interview and survey response to the modified Adolescent Medical Devices Assessment Toolkit (AMDAT)
Time frame: ACT will be assessed at enrollment, one month and three months.
Asthma control will be measured by the Asthma Control Test (range 0-25 with a higher score representing better asthma control). Change in ACT score will be assessed between baseline and one month and between baseline and three months. A change of 3 or more is considered a clinically significant change.
Time frame: The information will be collected at one month
This will be assessed by recording the number and percentage of the children and adolescents still using the Propeller EMD at one month.
Connecticut Children's Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07394127
Asthma, Asthma Chronic
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, Turkey (Türkiye)
View Trial DetailsNCT01678222
Allergic Inflammation, Asthma
Research Triangle Park, North Carolina, United States
View Trial DetailsNCT03937804
Asthma, Bronchial Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT03927820
Asthma, Bronchial Diseases
Nashville, Tennessee, United States
View Trial Details