Pilot Study of a Mobile Asthma Adherence Intervention

Overview

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].

Full Title of Study: “Pilot Study of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

Interventions

  • Device: Inhaler sensor
    • Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.
  • Behavioral: Mobile application for asthma adherence
    • Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.

Arms, Groups and Cohorts

  • Sham Comparator: Standard Care with Medication Monitoring
    • 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
  • Experimental: Medication Monitoring and Mobile App
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Real-time medication adherence in patients receiving reminders and incentives compared to standard care.
    • Time Frame: 12 weeks
    • Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm.

Secondary Measures

  • Asthma control in patients receiving reminders and incentives compared to standard care (Analysis of the ACT [asthma control test])
    • Time Frame: 12 weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CoheroHealth
  • Collaborator
    • Icahn School of Medicine at Mount Sinai
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrew M Ting, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai
    • Michael M Parides, PhD, Principal Investigator, Icahn School of Medicine at Mount Sinai

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