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

March 3, 2020 updated by: David Stukus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: AsthmaCare mobile health application
Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
Active Comparator: 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.
Other: Asthma education
A website with links to written asthma education and videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Asthma Exacerbations
Time Frame: 6 months
Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
6 months
Hospitalizations
Time Frame: 6 months
Number of hospitalizations for asthma exacerbation during 6 month study duration
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Stukus

Investigators

  • Principal Investigator: David Stukus, M.D., Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00678

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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