The goal of this clinical trial is to evaluate the aflo™ digital platform's ability to improve inhaler use technique and asthma control for children, adolescents, and adults with uncontrolled asthma. The main questions the trial aims to answer are: 1. Does the platform improve medication adherence and inhaler technique, as measured by the Inhaler Proficiency Score (IPS)? 2. Does the aflo™ platform improve asthma control, as measured by changes in the Asthma Control Test (ACT) and lung function tests (FEV1, PEF)? 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 assessment visits and surveys at the start and end of the 3-month study and 2 interim asthma assessment phone calls.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The intervention utilizes the aflo™ digital platform, a comprehensive system designed to improve asthma management through advanced technology. It integrates the following components: 1. Electronic Inhaler Sensor: The sensor attaches to a metered-dose inhaler (MDI) and a spacer (if applicable) to automate and provide feedback on the six critical steps of proper inhaler technique, such as shaking the inhaler, breathing out, inhaling slowly, and holding the breath. The sensor also records and stores medication usage data securely. 2. Mobile Application: The app delivers real-time notifications and feedback on inhaler technique, sends reminders for daily controller medication, tracks asthma symptoms, and provides monthly Asthma Control Test (ACT) assessments. It also offers reminders for spacer cleaning and customizable alerts for caregivers. 3. Clinician Portal: Data collected from the sensor and app is accessible via a secure clinician portal, enabling healthcare providers to monitor pa
Boston Children's Hospital
Boston, Massachusetts, United States
Change from Baseline in the participants' Inhaler Proficiency Score (IPS) Following Aflo™ Platform Usage at 3 Month
Inhaler Proficiency Score (IPS) is a validated, composite score that assesses the accuracy and consistency of inhaler technique, including steps such as inhaler preparation, actuation timing, inhalation depth, and breath hold. Scores range from 0 to 10, with higher scores indicating greater inhaler technique proficiency. Scores will be recorded at baseline and again after 3 months of using the Aflo™ digital platform, which provides step-by-step guidance and real-time feedback on inhaler technique. The outcome measure reflects the mean change in IPS from baseline to the 3-month follow-up to evaluate the effectiveness of the intervention.
Time frame: From enrollment to the end of intervention period at 12 weeks
Evaluation of the aflo™ Platform for Improving Asthma Control Using ACT Scores
This study assesses the impact of the aflo™ platform on asthma control, measured by changes in Asthma Control Test (ACT) scores. The ACT is a validated questionnaire used to evaluate asthma management, with scores ranging from 5 (poor control) to 25 (complete control). Participants will use the aflo™ platform, which provides real-time inhaler usage feedback via a connected device and mobile app. ACT scores will be collected at baseline and after the intervention to determine the platform's effectiveness in improving asthma outcomes.
Time frame: From enrollment to the end of intervention period at 12 weeks
Impact of the aflo™ Platform on Health-Related Quality of Life and Clinical Outcomes in Asthma
This study evaluates secondary outcomes of the aflo™ platform, including maximal percent changes in self- and parent-reported health-related quality of life using the St. George's Respiratory Questionnaire (SGRQ). Additional clinical outcome measures, such as lung function and symptom changes, will also be assessed. These measures aim to further understand the platform's effect on asthma management beyond asthma control.
Time frame: From enrollment to the end of intervention period at 12 weeks
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