Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma

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.

• Propeller EMD (Other): 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.

Primary outcomes

• Propeller Device Use at Three Months [3 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.

Secondary outcomes

• Acceptability of the Propeller EMD as Determined by the Electronic Medical Devices Assessment Toolkit (AMDAT) [Baseline, 1 month, and 3 months]: 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.
• Device Use at One Month [1 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.
• Asthma Control Test (ACT) Score [1 month and 3 months]: 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.
• Medication Adherence Measured by Propeller Device [3 months]: 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.

Sex: All, ages: 4 Years to 18 Years

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

Participant flow

Outcome results

• Propeller Device Use at Three Months (Primary), Count of participants, Participants: Propeller Smart Inhaler EMD 14
• Acceptability of the Propeller EMD as Determined by the Electronic Medical Devices Assessment Toolkit (AMDAT) (Secondary), Count of participants, Participants: Propeller Smart Inhaler EMD 13
• Device Use at One Month (Secondary), Count of participants, Participants: Propeller Smart Inhaler EMD 17
• Asthma Control Test (ACT) Score (Secondary), Mean, Score on a scale: Propeller Smart Inhaler EMD 19.7 (15 to 24)
• Medication Adherence Measured by Propeller Device (Secondary), Mean, percent: Propeller Smart Inhaler EMD 54 +/- 28

Adverse events

Time frame: From enrollment until study completion, up to 12 weeks.

• Study Protocol and Statistical Analysis Plan (PDF, 2022-06-23)
• Informed Consent Form: English (PDF, 2022-06-20)
• Informed Consent Form: Spanish (PDF, 2022-06-20)

• Glenn Flores, MD, Study director, Connecticut Children's Medical Center