Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management (AsthmaCare)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AsthmaCare mobile health application
Asthma education
Sponsored by

About this trial
This is an interventional prevention trial for Asthma focused on measuring asthma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AsthmaCare intervention
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Emergency Room Visits Secondary to Asthma Exacerbation
Number of emergency room visits for asthma 6 months following study enrollment and randomization
Secondary Outcome Measures
Number of Asthma Exacerbations
Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
Hospitalizations
Number of hospitalizations for asthma exacerbation during 6 month study duration
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02333630
Brief Title
Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
Acronym
AsthmaCare
Official Title
Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Stukus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AsthmaCare intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
AsthmaCare mobile health application
Intervention Description
Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
Intervention Type
Other
Intervention Name(s)
Asthma education
Intervention Description
A website with links to written asthma education and videos
Primary Outcome Measure Information:
Title
Number of Emergency Room Visits Secondary to Asthma Exacerbation
Description
Number of emergency room visits for asthma 6 months following study enrollment and randomization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Asthma Exacerbations
Description
Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
Time Frame
6 months
Title
Hospitalizations
Description
Number of hospitalizations for asthma exacerbation during 6 month study duration
Time Frame
6 months
Title
Frequency of Use of the Mobile Health Application
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Stukus, M.D.
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23770578
Citation
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.
Results Reference
background
PubMed Identifier
23171675
Citation
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.
Results Reference
background
PubMed Identifier
23349621
Citation
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.
Results Reference
background
PubMed Identifier
24282112
Citation
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.
Results Reference
background
PubMed Identifier
24565615
Citation
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.
Results Reference
background
PubMed Identifier
29452259
Citation
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.
Results Reference
derived
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Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
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