Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management

Study Overview
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Brief Summary
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The investigators aim to study the clinical efficacy of a mobile health application, AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel application developed by members of the study team that was previously studied in a pilot study of 21 children/teenagers 9-16 years old. During the 30 day pilot study, there was universal usage and acceptance by all participants of this novel form of technology and asthma management. This current study aims to measure clinical outcomes for users of the app.

Detailed Description
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AsthmaCare is a novel mobile health application that integrates personalized asthma reminders with self management feedback. Users input their prescribed daily controller medications and personal asthma triggers upon first loading the app. Reminder messages are pushed through the device at predetermined times to take controller medications. Once daily push notifications are sent to the user regarding tips to avoid preselected asthma triggers. Users are asked to input their use of controller medications, which is entered into a medication log. Every interaction will unlock reward points as gaming theory is integrated into AsthmaCare to maintain user engagement. If symptoms occur or if rescue medication use is logged into AsthmaCare, the user is automatically directed to an interactive asthma self-management plan, aka written asthma treatment plan. When users are in the yellow zone, they receive notifications every 4 hours regarding symptom update or rescue medication use. When users are in the red zone, these notifications occur every 1 hour. When users are in the green zone (baseline, no symptoms), they will receive motivational messages every 24 hours to maintain engagement with the app as well as remind them to continue to use controller medications. In addition to medication reminders and an interactive self-management plan, AsthmaCare provides links to the nearest National Pollen Bureau counting station and allows for symptom/medication diaries to be emailed for sharing with providers or printing. Mobile health applications, particularly for asthma, have not been studies in prospective clinical trials to demonstrate ongoing user engagement or efficacy. This study aims to determine whether users of an asthma mobile health application will have superior clinical outcomes compared with traditional asthma management.

Official Title
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Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management

Conditions
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Asthma

Intervention / Treatment
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* Other: AsthmaCare mobile health application
* Other: Asthma education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosis of persistent asthma defined by treatment with at least one daily controller medication Fluent English speaking Subject must have access to an iOS or Android device in order to download and use the mobile health application At least one Emergency Department or Urgent Care visit due to asthma exacerbation in the 12 months prior to enrollment Exclusion Criteria: No prescription/recommendation to use a daily controller medication Non-English speaking Lack of access to an iOS or Android device Current or prior use of AsthmaCare mobile health application at any time. Research assistant will assess by reviewing beforehand a complete list of people who have already downloaded the app

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 21 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AsthmaCare intervention<br>Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment. | Other: AsthmaCare mobile health application<br>* Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management<br>|
| Active Comparator: Control group<br>Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion. | Other: Asthma education<br>* A website with links to written asthma education and videos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Emergency Room Visits Secondary to Asthma Exacerbation | Number of emergency room visits for asthma 6 months following study enrollment and randomization | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Asthma Exacerbations | Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame | 6 months | 
| Hospitalizations | Number of hospitalizations for asthma exacerbation during 6 month study duration | 6 months | 
| Frequency of Use of the Mobile Health Application | Analytics from within the mobile application will be measured to determine the frequency and usage patterns of the mobile health application by users during the study period | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma