Using Mobile Phones to Improve Adherence to Inhaled Steroids (ADEPT4)
|ClinicalTrials.gov Identifier: NCT01710059|
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : February 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Asthma Supervision Behavioral: Mobile Phone Behavioral: Inhaled Corticosteroid Mobile Phone Application Behavioral: Beta2-adrenergic agonist Mobile Phone Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Refined ADEPT: Human Augmentics for Sustained Wellbeing|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710059
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Giselle S. Mosnaim, MD, MS||Rush University Medical Center|