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Pilot Study of a Mobile Asthma Adherence Intervention

Primary Purpose

Asthma

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inhaler sensor
Mobile application for asthma adherence
Sponsored by
CoheroHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Patient Compliance, Mobile Applications

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 11-19
  • Asthma diagnosis
  • Currently on a daily controller HFA (hydrofluoroalkane) medication for Asthma
  • English-speaking
  • Has a smartphone or access to a smartphone or tablet

Exclusion Criteria:

  • Pregnant
  • Foster Care
  • Emancipated minor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Standard Care with Medication Monitoring

    Medication Monitoring and Mobile App

    Arm Description

    Patients will be given an inhaler sensor to monitor medication use and a sham version of the mobile app that will not include reminders or incentives. Intervention: Inhaler sensor

    Patients will be given an inhaler sensor to monitor medication use and a mobile phone application that will send them reminders and provide an opportunity to see their own medication use and win incentives for adherence. Interventions: Inhaler sensor and mobile application for asthma adherence

    Outcomes

    Primary Outcome Measures

    Real-time medication adherence in patients receiving reminders and incentives compared to standard care.
    Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm.

    Secondary Outcome Measures

    Asthma control in patients receiving reminders and incentives compared to standard care (Analysis of the ACT [asthma control test])
    Analysis of the ACT [asthma control test] at baseline and follow up for patients in each arm to assess changes in asthma control with use of the mobile app.

    Full Information

    First Posted
    April 7, 2015
    Last Updated
    August 3, 2016
    Sponsor
    CoheroHealth
    Collaborators
    Icahn School of Medicine at Mount Sinai
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02413528
    Brief Title
    Pilot Study of a Mobile Asthma Adherence Intervention
    Official Title
    Pilot Study of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    Wireless connectivity challenges with device and mobile app
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CoheroHealth
    Collaborators
    Icahn School of Medicine at Mount Sinai

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess medication use throughout the study in patients who receive a mobile app with reminders and asthma control as measured by the ACT [asthma control test].

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Patient Compliance, Mobile Applications

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care with Medication Monitoring
    Arm Type
    Sham Comparator
    Arm Description
    Patients will be given an inhaler sensor to monitor medication use and a sham version of the mobile app that will not include reminders or incentives. Intervention: Inhaler sensor
    Arm Title
    Medication Monitoring and Mobile App
    Arm Type
    Experimental
    Arm Description
    Patients will be given an inhaler sensor to monitor medication use and a mobile phone application that will send them reminders and provide an opportunity to see their own medication use and win incentives for adherence. Interventions: Inhaler sensor and mobile application for asthma adherence
    Intervention Type
    Device
    Intervention Name(s)
    Inhaler sensor
    Intervention Description
    Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mobile application for asthma adherence
    Intervention Description
    Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.
    Primary Outcome Measure Information:
    Title
    Real-time medication adherence in patients receiving reminders and incentives compared to standard care.
    Description
    Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Asthma control in patients receiving reminders and incentives compared to standard care (Analysis of the ACT [asthma control test])
    Description
    Analysis of the ACT [asthma control test] at baseline and follow up for patients in each arm to assess changes in asthma control with use of the mobile app.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 11-19 Asthma diagnosis Currently on a daily controller HFA (hydrofluoroalkane) medication for Asthma English-speaking Has a smartphone or access to a smartphone or tablet Exclusion Criteria: Pregnant Foster Care Emancipated minor
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew M Ting, MD
    Organizational Affiliation
    Icahn School of Medicine at Mount Sinai
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Michael M Parides, PhD
    Organizational Affiliation
    Icahn School of Medicine at Mount Sinai
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pilot Study of a Mobile Asthma Adherence Intervention

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