Using Mobile Phones to Improve Adherence to Inhaled Steroids

NCT ID: NCT01710059

Last Updated: 2014-02-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-11-30

Brief Summary

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This study has two main goals. The first goal is to test whether a mobile phone intervention can increase adherence to daily inhaled steroid medications in African American adolescents prescribed this type of medication by his/her asthma doctor. The second goal is to use a mobile phone intervention to better understand real life patterns of use of quick-relief (beta2-adrenergic agonist) asthma medication in this population.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Experimental: Intervention Group

Experimental: Intervention Group

1\) Asthma Supervision; 2) Mobile Phone with talking, texting, and data plan; 3) Inhaled Corticosteroid Mobile Phone Application to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated; and 4) Beta2-adrenergic agonist Mobile Phone Application to monitor real time patterns of use of beta2-adrenergic agonist medication for asthma.

Group Type EXPERIMENTAL

Asthma Supervision

Intervention Type BEHAVIORAL

Each participant will be provided with a spacer and a peak flow meter, and instructions on proper technique, by a member of the study team during the baseline period. They will also meet with study staff at study visits during the active treatment phase to review their adherence to daily inhaled corticosteroids and usage patterns of short acting B2-agonist medication.

Mobile Phone

Intervention Type BEHAVIORAL

Each participant will receive a mobile phone with talking, texting and a data plan. They will get to keep the mobile phone at the end of the study, but the talking, texting and data plan will only be active during their participation in the study.

Inhaled Corticosteroid Mobile Phone Application

Intervention Type BEHAVIORAL

The Inhaled Corticosteroid Mobile Phone Application will be used to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated.

Beta2-adrenergic agonist Mobile Phone Application

Intervention Type BEHAVIORAL

The Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication.

Interventions

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Asthma Supervision

Each participant will be provided with a spacer and a peak flow meter, and instructions on proper technique, by a member of the study team during the baseline period. They will also meet with study staff at study visits during the active treatment phase to review their adherence to daily inhaled corticosteroids and usage patterns of short acting B2-agonist medication.

Intervention Type BEHAVIORAL

Mobile Phone

Each participant will receive a mobile phone with talking, texting and a data plan. They will get to keep the mobile phone at the end of the study, but the talking, texting and data plan will only be active during their participation in the study.

Intervention Type BEHAVIORAL

Inhaled Corticosteroid Mobile Phone Application

The Inhaled Corticosteroid Mobile Phone Application will be used to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated.

Intervention Type BEHAVIORAL

Beta2-adrenergic agonist Mobile Phone Application

The Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 11-16 years of age
* self-identify as African American
* have persistent asthma
* be on a prescription daily inhaled corticosteroid medication for asthma
* be on a prescription inhaled beta2-adrenergic agonist medication for asthma

Exclusion Criteria

* candidate refusal
* the presence of other co-morbidities that could interfere wtih study participation
* \> 60% adherence to inhaled corticosteroid medication, measured by the electronic dose counter, during the run-in period
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Giselle Mosnaim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giselle S. Mosnaim, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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5K23HL092292-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10010402

Identifier Type: -

Identifier Source: org_study_id

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