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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AsthmaCare intervention | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AsthmaCare mobile health application | Other | Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Stukus, M.D. | Nationwide Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23770578 | Background | Martinez-Perez B, de la Torre-Diez I, Lopez-Coronado M. Mobile health applications for the most prevalent conditions by the World Health Organization: review and analysis. J Med Internet Res. 2013 Jun 14;15(6):e120. doi: 10.2196/jmir.2600. | |
| 23171675 | Background | Huckvale K, Car M, Morrison C, Car J. Apps for asthma self-management: a systematic assessment of content and tools. BMC Med. 2012 Nov 22;10:144. doi: 10.1186/1741-7015-10-144. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management |
| FG001 | 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. Asthma education: A website with links to written asthma education and videos |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Emergency Room Visits Secondary to Asthma Exacerbation | Number of emergency room visits for asthma 6 months following study enrollment and randomization | Posted | Mean | Standard Deviation | visits | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Stukus, MD | Nationwide Children's Hospital | 614 722-4808 | david.stukus@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Asthma education | Other | A website with links to written asthma education and videos |
|
| 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 |
| 23349621 | Background | Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. doi: 10.1371/journal.pmed.1001362. Epub 2013 Jan 15. |
| 24282112 | Background | Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2. |
| 24565615 | Background | Chan AH, Reddel HK, Apter A, Eakin M, Riekert K, Foster JM. Adherence monitoring and e-health: how clinicians and researchers can use technology to promote inhaler adherence for asthma. J Allergy Clin Immunol Pract. 2013 Sep-Oct;1(5):446-54. doi: 10.1016/j.jaip.2013.06.015. Epub 2013 Aug 30. |
| 29452259 | Derived | Stukus DR, Farooqui N, Strothman K, Ryan K, Zhao S, Stevens JH, Cohen DM. Real-world evaluation of a mobile health application in children with asthma. Ann Allergy Asthma Immunol. 2018 Apr;120(4):395-400.e1. doi: 10.1016/j.anai.2018.02.006. Epub 2018 Feb 13. |
| BG001 | 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. Asthma education: A website with links to written asthma education and videos |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insurance Provider | Count of Participants | Participants |
|
| Controller medications | Count of Participants | Participants |
|
| Health Care Utilization for Asthma Exacerbations During 6 Months Prior to Enrollment | Mean | Standard Deviation | visits |
|
|
|
| Secondary | Number of Asthma Exacerbations | Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame | Data were not collected for this outcome measure | Posted | 6 months |
|
|
| Secondary | Hospitalizations | Number of hospitalizations for asthma exacerbation during 6 month study duration | Posted | Mean | Standard Deviation | visits | 6 months |
|
|
|
| Secondary | 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 | Data were not collected for this measure | Posted | 6 months |
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | 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. Asthma education: A website with links to written asthma education and videos | 0 | 95 | 0 | 95 | 0 | 95 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |