Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

April 24, 2015 updated by: CoheroHealth

Feasibility of a Mobile Intervention to Increase Adherence to Asthma Medication Among Children Age 11 to 19 in an Urban Setting

The purpose of this study is to assess the feasibility of using a mobile health intervention to improve adherence to asthma medication among adolescents in an urban clinic setting. 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 the feasibility and acceptability of this intervention to patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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 medication for Asthma
  • English-speaking

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients in this arm were given no intervention. Their self-reported medication adherence was assessed at the baseline (week 0) and follow-up (week 12) visits but during the study period they did not receive any intervention.
Sham Comparator: Medication Sensor Only

These patients received the medication use sensor (sham intervention) and downloaded a sham version of the mobile app. Thus, the medication use from these patients was able to be recorded but the patients did not receive reminders or incentives or the ability to see their medication use via the real mobile app.

Intervention: inhaler sensor
Device: Inhaler sensor
Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.
Experimental: Medication Sensor and Mobile App

These patients received the medication use sensor and the mobile app with reminders (intervention arm).

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
Evidence of ability to monitor medication use at home via a sensor strap
Time Frame: 12 weeks
Ability to measure medication use via the sensor strap and upload that information to the HIPAA (Health Insurance Portability and Accountability Act) compliant server.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient feedback for improved design of a mobile adherence tool
Time Frame: 12 weeks
Feedback from patients on the design of the inhaler sensor and mobile app including aesthetics and ease of use.
12 weeks
Acceptability of mobile adherence strategy for adolescents with asthma (Based on questions as part of baseline/followup visits and focus group.)
Time Frame: 12 weeks
Based on questions as part of baseline/followup visits and focus group.
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (Estimate)

April 27, 2015

Study Record Updates

Last Update Posted (Estimate)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014_Spring_Feasibility

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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