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

NCT ID: NCT02426814

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type SHAM_COMPARATOR

Inhaler sensor

Intervention Type DEVICE

Inhaler sensor strap that tracks inhaler use.

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

Group Type EXPERIMENTAL

Inhaler sensor

Intervention Type DEVICE

Inhaler sensor strap that tracks inhaler use.

Mobile application for asthma adherence

Intervention Type BEHAVIORAL

Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.

Interventions

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Inhaler sensor

Inhaler sensor strap that tracks inhaler use.

Intervention Type DEVICE

Mobile application for asthma adherence

Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

CoheroHealth

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Ting, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Michael Parides, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2015_Spring_Sinai

Identifier Type: -

Identifier Source: org_study_id

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