AsthmaNCT03648450
Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma
An observational study of Asthma, run by Connecticut Children's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Propeller EMD
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 Aug 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The target population consists of children and adolescents 4-18 years old making an ED visit or admitted to the hospital at Connecticut Children's Medical Center for an asthma exacerbation.
Who may be able to join
- Children in the ED or inpatient setting presenting with an asthma exacerbation between 4-18 years old
- History of persistent asthma (defined as prescribed a controller medication)
- Both the child and primary caregiver/parent have access to a cell phone with an activated number
- Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.
Who cannot join
- Child or parent has no access to a personal cell phone.
- The child has another chronic pulmonary condition (for example, cystic fibrosis)
- Having any chronic condition that could affect the child's ability to participate in the study (examples: cancer, autism, or cerebral palsy)
- The subject has an inhaler medication besides the following, given these are the current medications compatible with the Propeller EMD.
- Advair HFA ii. Flovent HFA iii. QVAR HFA v. Ventolin HFA vi. ProAir HFA
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
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.
Read the detailed description
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.
- Conditions
- Asthma
- Being tested
- Propeller EMD
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propeller EMDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Propeller Smart Inhaler EMD | All enrolled participants will be given the Propeller 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. Receives: Other: Propeller EMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propeller Device Use at Three Months
Device use will be assessed by recording the number and percentage of children and adolescents still using the Propeller electronic monitoring device at 3 months following enrollment.
Measured: 3 months
Secondary outcomes (4)
Acceptability of the Propeller EMD as Determined by the Electronic Medical Devices Assessment Toolkit (AMDAT)
Acceptability of the Propeller electronic monitoring device will be assessed through phone interviews and participant survey responses using the modified Adolescent Medical Devices Assessment Toolkit (AMDAT). Surveys will be administered at baseline, 1 month, and 3 months following enrollment to assess user experience, usability, and comfort using the device.
Measured: Baseline, 1 month, and 3 months
Device Use at One Month
Device use will be assessed by recording the number and percentage of children and adolescents using the Propeller electronic monitoring device at 1 month following enrollment.
Measured: 1 month
Asthma Control Test (ACT) Score
Asthma control will be measured using the Asthma Control Test (ACT), a validated questionnaire with scores ranging from 0 to 25, where higher scores indicate better asthma control. ACT will be assessed at baseline, 1 month, and 3 months after enrollment. Changes in ACT score over time will be evaluated, with a change of 3 or more points considered clinically meaningful.
Measured: 1 month and 3 months
Medication Adherence Measured by Propeller Device
EMD adherence was calculated for the intervention group after enrollment. Real-time inhaled corticosteroid (ICS) administration information (number of, time and date of puffs actuated) was obtained. Daily rate of adherence measured by EMD was defined as the number of actuated puffs on each day divided by the expected number of puffs, maxed at 100% to avoid overestimation due to intentional "dumping" or unintentional over-usage of medication. Average EMD adherence was calculated at 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Nov 2020
- Primary completion31 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Hollenbach, Connecticut Children's Medical Center
- Investigators
- Glenn Flores, MD, Study director, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648450
- Sponsor's protocol ID
- Propeller Asthma Study
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2018
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No