Feasibility and Acceptability of the Hailie Monitoring System in Children With Persistent Asthma
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|ClinicalTrials.gov Identifier: NCT03648450|
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment|
|Asthma||Other: Hailie Smart Inhaler EMD|
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 Hailie devices (for controller and rescue inhalers), an App for their smartphone, and a free Hailie 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 Hailie 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. Adherium 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 Hailie 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 Adherium's Hailie 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 Hailie device.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Feasibility and Acceptability of the Hailie Monitoring System in Children With Persistent Asthma|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Hailie Smart Inhaler EMD
All enrolled participants will be given the Hailie Smart Inhaler electronic monitoring device to use for three months to track how often they are using their inhalers either for their regular medication or as a rescue dose.
Other: Hailie Smart Inhaler EMD
Hailie Smart Inhaler electronic monitoring device is a sleeve that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication.
- Regular device use at three months [ 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 the Hailie Smart Inhaler at three months.
- Acceptability of the Hailie Smartinhaler as determined by the Adolescent Medical Devices Assessment Toolkit (AMDAT) [ 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)
- Asthma Control [ 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.
- Device use at one month [ 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 Hailie Smart Inhaler at one month.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648450
|Contact: Tregony Simoneau, MDfirstname.lastname@example.org|
|Contact: Eliza G Bakeremail@example.com|
|United States, Connecticut|
|Connecticut Children's Medical Center||Recruiting|
|Hartford, Connecticut, United States, 06106|
|Contact: Eliza G Baker 860-819-1012 firstname.lastname@example.org|
|Principal Investigator: Tregony Simoneau, M.D.|
|Study Director:||Glenn Flores, MD||Connecticut Children's Medical Center|