Smart Inhaler Monitoring for Asthma
(AIM Trial)

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Children's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the aflo™ digital platform's ability to improve asthma control and inhaler technique for children, adolescents, and adults with uncontrolled asthma. The main questions the trial aims to answer are: 1. Does the aflo™ platform improve asthma control, as measured by changes in the Asthma Control Test (ACT) and lung function tests (FEV1, PEF)? 2. Does the platform improve medication adherence and inhaler technique, as measured by the Inhaler Proficiency Score (IPS)? Participants will: * Use the aflo™ sensor with their asthma inhaler to receive real-time feedback on technique and medication adherence reminders. * Track asthma symptoms and quality of life through a mobile app. * Complete assessments and surveys at the start and end of the 3-month study and 2 interim asthma assessment phone calls.

Eligibility Criteria

This trial is for children, adolescents, and adults with uncontrolled asthma. Participants will use a smart inhaler monitoring platform to help manage their condition. They must be willing to track symptoms and quality of life through an app and complete assessments throughout the 3-month study.

Inclusion Criteria

I have been diagnosed with persistent asthma.

I am at least 10 years old.

Participant or caregiver must have an Apple and/or Android smart phone with operating system 4.3 or above and data plan for the duration of the study period

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Exclusion Criteria

Participants with documented developmental delays or impairments that would interfere with ability to use aflo™ system

The participant's guardian or the patient has comprehension or language difficulties that prevent understanding of study materials (available in English) or effective training on the app or device

I have a condition affecting my breathing but not asthma.

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Treatment Details

Interventions

Smart Inhaler Monitoring Platform (Behavioural Intervention)

Trial OverviewThe aflo™ digital platform is being tested for its effectiveness in improving asthma control and inhaler technique. The study measures changes in Asthma Control Test scores, lung function tests (FEV1, PEF), medication adherence, and proficiency in using an inhaler.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Intervention groupExperimental Treatment1 Intervention

Participants will use the aflo™ digital platform, which includes an electronic inhaler sensor, a mobile application, and a clinician portal. The platform provides real-time feedback on inhaler technique and sends medication reminders to improve adherence. Participants will also receive daily symptom tracking prompts and monthly Asthma Control Test (ACT) assessments. During the study, participants will: * Attach the aflo™ sensor to their metered-dose inhaler (MDI) and use it with or without a spacer, based on their prescribed regimen. * Complete at least one supervised inhalation session during the baseline visit to ensure proper use of the sensor. * Use the aflo™ mobile app to log asthma symptoms, medication usage, and track reminders. * Participate in two clinic visits (at baseline and study completion) and two follow-up phone calls (at weeks 4 and 8) to monitor progress.