Using Mobile Phones to Improve Adherence to Inhaled Steroids

Asthma Clinical Trial

— ADEPT4  

Official title:

Refined ADEPT: Human Augmentics for Sustained Wellbeing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710059
• Other study ID #: 10010402
• Secondary ID: 5K23HL092292-04
• Status: Completed
• Phase: N/A
• First received: October 16, 2012
• Last updated: February 10, 2014
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	GlaxoSmithKline, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter	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	No
Secondary	To understand patterns of use of quick-relief medication for asthma	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	No