Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents

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 a 12 week study in patients who receive a mobile app with reminders, asthma control as measured by the ACT [asthma control test], and lung function as measured by spirometry.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2017

Interventions

  • Device: Inhaler sensor
    • Inhaler sensor strap that tracks inhaler use.
  • Behavioral: Mobile application for asthma adherence
    • Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.

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 with reminders to allow self-management of medication use. Interventions: inhaler sensor and mobile application for asthma adherence

Clinical Trial Outcome Measures

Primary Measures

  • Real-time medication adherence in patients using mobile app 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 using mobile app compared to standard care
    • 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.
  • Change in lung function with use of a mobile health tool for asthma adherence
    • Time Frame: 12 weeks
    • Measure change in spirometry by comparing force expiratory volume at one second [FEV1] and forced vital capacity [FVC] at baseline and 12 week visit.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 11-19
  • Asthma diagnosis
  • Currently prescribed a hydrofluoroalkane (HFA) asthma controller medication
  • 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 Ting, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai
    • Michael Parides, PhD, Principal Investigator, Icahn School of Medicine at Mount Sinai

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