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OpenTrials
Completed

NCT Number: NCT02333630

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

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.

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Key information

Age range

6 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AsthmaCare mobile health application

Other

Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management

Asthma Education

Other

A website with links to written asthma education and videos

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Asthma Exacerbations

    Time frame: 6 months

    Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame

  2. Hospitalizations

    Time frame: 6 months

    Number of hospitalizations for asthma exacerbation during 6 month study duration

  3. 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

Sponsors and collaborators

Lead sponsor

David Stukus

Other

Registry information

Acronym: AsthmaCare

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 7, 2015
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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