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

Asthma Clinical Trial

— AsthmaCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333630
• Other study ID #: IRB14-00678
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: May 2017

Study information

• Verified date: March 2020
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• AsthmaCare mobile health application
Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
• Asthma education
A website with links to written asthma education and videos

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
David Stukus

References & Publications (5)

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. — View 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. Review. — View 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. Review. — View 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;(11):CD010013. doi: 10.1002/14651858.CD010013.pub2. Review. — View Citation

Martínez-Pérez B, de la Torre-Díez I, López-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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Asthma Exacerbations	Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame	6 months
Secondary	Hospitalizations	Number of hospitalizations for asthma exacerbation during 6 month study duration	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	6 months