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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AsthmaCare mobile health application
Asthma education
Sponsored by
David Stukus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma

Eligibility Criteria

6 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    AsthmaCare intervention

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of Emergency Room Visits Secondary to Asthma Exacerbation
    Number of emergency room visits for asthma 6 months following study enrollment and randomization

    Secondary Outcome Measures

    Number of Asthma Exacerbations
    Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
    Hospitalizations
    Number of hospitalizations for asthma exacerbation during 6 month study duration
    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

    Full Information

    First Posted
    December 17, 2014
    Last Updated
    March 3, 2020
    Sponsor
    David Stukus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02333630
    Brief Title
    Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
    Acronym
    AsthmaCare
    Official Title
    Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    David Stukus

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    asthma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AsthmaCare intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    AsthmaCare mobile health application
    Intervention Description
    Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
    Intervention Type
    Other
    Intervention Name(s)
    Asthma education
    Intervention Description
    A website with links to written asthma education and videos
    Primary Outcome Measure Information:
    Title
    Number of Emergency Room Visits Secondary to Asthma Exacerbation
    Description
    Number of emergency room visits for asthma 6 months following study enrollment and randomization
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of Asthma Exacerbations
    Description
    Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
    Time Frame
    6 months
    Title
    Hospitalizations
    Description
    Number of hospitalizations for asthma exacerbation during 6 month study duration
    Time Frame
    6 months
    Title
    Frequency of Use of the Mobile Health Application
    Description
    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
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Stukus, M.D.
    Organizational Affiliation
    Nationwide Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23770578
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23171675
    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.
    Results Reference
    background
    PubMed Identifier
    23349621
    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.
    Results Reference
    background
    PubMed Identifier
    24282112
    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;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.
    Results Reference
    background
    PubMed Identifier
    24565615
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29452259
    Citation
    Stukus 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.
    Results Reference
    derived

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

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