Using Mobile Phones to Improve Adherence to Inhaled Steroids (ADEPT4)

February 10, 2014 updated by: Giselle Mosnaim, Rush University Medical Center

Refined ADEPT: Human Augmentics for Sustained Wellbeing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

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 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter
Time Frame: 10 weeks
Adherence is measured as the mean of daily adherence to prescription inhaled corticosteroid dose over 14 days both at baseline and at week 10 of the active treatment phase. For the primary outcome, we will compare adherence at week 10 to adherence at baseline.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To understand patterns of use of quick-relief medication for asthma
Time Frame: 10 weeks
This study will use an electronic dose counter and mobile phone technology to track participants real time use of quick-relief (beta2-adrenergic agonist) medication for asthma during the 10 weeks of active treatment.
10 weeks

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline

Investigators

  • Principal Investigator: Giselle S. Mosnaim, MD, MS, Rush University Medical Center

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

December 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 16, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10010402
  • 5K23HL092292-04 (U.S. NIH Grant/Contract)

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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