Pilot Study of a Mobile Asthma Adherence Intervention

August 3, 2016 updated by: CoheroHealth

Pilot Study of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents

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].

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

Genders Eligible for Study

All

Description

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

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 via a pressure sensitive switch.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 M Ting, MD, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Michael M 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

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014_Fall_2014_Sinai

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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