Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

Study Overview
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Brief Summary
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The purpose of this study is to assess the feasibility of using a mobile health intervention to improve adherence to asthma medication among adolescents in an urban clinic setting. 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 the feasibility and acceptability of this intervention to patients.

Official Title
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Feasibility of a Mobile Intervention to Increase Adherence to Asthma Medication Among Children Age 11 to 19 in an Urban Setting

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 on a daily controller medication for Asthma English-speaking 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in this arm were given no intervention. Their self-reported medication adherence was assessed at the baseline (week 0) and follow-up (week 12) visits but during the study period they did not receive any intervention. | |
| Sham Comparator: Medication Sensor Only<br>These patients received the medication use sensor (sham intervention) and downloaded a sham version of the mobile app. Thus, the medication use from these patients was able to be recorded but the patients did not receive reminders or incentives or the ability to see their medication use via the real mobile app. Intervention: inhaler sensor | Device: Inhaler sensor<br>* Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.<br>|
| Experimental: Medication Sensor and Mobile App<br>These patients received the medication use sensor and the mobile app with reminders (intervention arm). Interventions: inhaler sensor and mobile application for asthma adherence | Device: Inhaler sensor<br>* Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.<br>Behavioral: Mobile application for asthma adherence<br>* Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of ability to monitor medication use at home via a sensor strap | Ability to measure medication use via the sensor strap and upload that information to the HIPAA (Health Insurance Portability and Accountability Act) compliant server. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient feedback for improved design of a mobile adherence tool | Feedback from patients on the design of the inhaler sensor and mobile app including aesthetics and ease of use. | 12 weeks | 
| Acceptability of mobile adherence strategy for adolescents with asthma (Based on questions as part of baseline/followup visits and focus group.) | Based on questions as part of baseline/followup visits and focus group. | 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, Medication Adherence