Using Mobile Phones to Improve Adherence to Inhaled Steroids
ADEPT4
Refined ADEPT: Human Augmentics for Sustained Wellbeing
2 other identifiers
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Dec 2012
Shorter than P25 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFebruary 12, 2014
February 1, 2014
11 months
October 16, 2012
February 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To understand patterns of use of quick-relief medication for asthma
10 weeks
Study Arms (1)
Experimental: Intervention Group
EXPERIMENTALExperimental: 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.
Interventions
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.
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.
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.
The Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- GlaxoSmithKlinecollaborator
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giselle S. Mosnaim, MD, MS
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2012
First Posted
October 18, 2012
Study Start
December 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
February 12, 2014
Record last verified: 2014-02