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OpenTrials
Completed

NCT Number: NCT01710059

Using Mobile Phones to Improve Adherence to Inhaled Steroids

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asthma Supervision

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

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

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

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

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

Registry information

Official study title

Refined ADEPT: Human Augmentics for Sustained Wellbeing

Acronym: ADEPT4

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 18, 2012
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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