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

July 24, 2023 updated by: CoheroHealth
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Inhaler sensor
Inhaler sensor strap that tracks inhaler use.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoheroHealth

Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Andrew Ting, MD, Icahn School of Medicine At Mount Sinai
  • Principal Investigator: Michael Parides, PhD, Icahn School of Medicine At Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

July 1, 2023

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (Estimated)

April 27, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_Spring_Sinai

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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