Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management (AsthmaCare)
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|ClinicalTrials.gov Identifier: NCT02333630|
Recruitment Status : Completed
First Posted : January 7, 2015
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Other: AsthmaCare mobile health application Other: Asthma education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||May 2017|
Experimental: AsthmaCare intervention
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
Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
Active Comparator: Control group
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
A website with links to written asthma education and videos
- Number of Emergency Room Visits Secondary to Asthma Exacerbation [ Time Frame: 6 months ]Number of emergency room visits for asthma 6 months following study enrollment and randomization
- Number of Asthma Exacerbations [ Time Frame: 6 months ]Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
- Hospitalizations [ Time Frame: 6 months ]Number of hospitalizations for asthma exacerbation during 6 month study duration
- Frequency of Use of the Mobile Health Application [ Time Frame: 6 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333630
|Principal Investigator:||David Stukus, M.D.||Nationwide Children's Hospital|