Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
AsthmaCare
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Nov 2014
Typical duration for not_applicable asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
January 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
March 11, 2020
CompletedMarch 11, 2020
March 1, 2020
2 years
December 17, 2014
March 15, 2018
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Number of Asthma Exacerbations
6 months
Hospitalizations
6 months
Frequency of Use of the Mobile Health Application
6 months
Study Arms (2)
AsthmaCare intervention
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Stukuslead
Related Publications (6)
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.
PMID: 23770578BACKGROUNDHuckvale 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.
PMID: 23171675BACKGROUNDFree 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.
PMID: 23349621BACKGROUNDMarcano 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.
PMID: 24282112BACKGROUNDChan 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.
PMID: 24565615BACKGROUNDStukus 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.
PMID: 29452259DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Stukus, MD
- Organization
- Nationwide Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
David Stukus, M.D.
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 17, 2014
First Posted
January 7, 2015
Study Start
November 1, 2014
Primary Completion
November 1, 2016
Study Completion
May 1, 2017
Last Updated
March 11, 2020
Results First Posted
March 11, 2020
Record last verified: 2020-03