Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02333630
Recruitment Status : Completed
First Posted : January 7, 2015
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
David Stukus, Nationwide Children's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Asthma Other: AsthmaCare mobile health application Other: Asthma education Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333630


Sponsors and Collaborators
David Stukus
Investigators
Layout table for investigator information
Principal Investigator: David Stukus, M.D. Nationwide Children's Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: David Stukus, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02333630    
Other Study ID Numbers: IRB14-00678
First Posted: January 7, 2015    Key Record Dates
Results First Posted: March 11, 2020
Last Update Posted: March 11, 2020
Last Verified: March 2020
Keywords provided by David Stukus, Nationwide Children's Hospital:
asthma
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases