Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents

Study Overview
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Brief Summary
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The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess medication use throughout a 12 week study in patients who receive a mobile app with reminders, asthma control as measured by the ACT [asthma control test], and lung function as measured by spirometry.

Official Title
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Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents

Conditions
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Asthma

Intervention / Treatment
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* Device: Inhaler sensor
* Behavioral: Mobile application for asthma adherence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 11-19 Asthma diagnosis Currently prescribed a hydrofluoroalkane (HFA) asthma controller medication English-speaking Has a smartphone or access to a smartphone or tablet Exclusion Criteria: Pregnant Foster Care Emancipated minor

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard Care with Medication Monitoring<br>Patients will be given an inhaler sensor to monitor medication use and a sham version of the mobile app that will not include reminders or incentives. Intervention: inhaler sensor | Device: Inhaler sensor<br>* Inhaler sensor strap that tracks inhaler use.<br>|
| Experimental: Medication Monitoring and Mobile App<br>Patients will be given an inhaler sensor to monitor medication use and a mobile phone application with reminders to allow self-management of medication use. Interventions: inhaler sensor and mobile application for asthma adherence | Device: Inhaler sensor<br>* Inhaler sensor strap that tracks inhaler use.<br>Behavioral: Mobile application for asthma adherence<br>* Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-time medication adherence in patients using mobile app compared to standard care. | Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control in patients using mobile app compared to standard care | Analysis of the ACT [asthma control test] at baseline and follow up for patients in each arm to assess changes in asthma control with use of the mobile app. | 12 weeks | 
| Change in lung function with use of a mobile health tool for asthma adherence | Measure change in spirometry by comparing force expiratory volume at one second [FEV1] and forced vital capacity [FVC] at baseline and 12 week visit. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Compliance, Mobile Applications