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Using Mobile Phones to Improve Adherence to Inhaled Steroids

Refined ADEPT: Human Augmentics for Sustained Wellbeing

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01710059
Acronym
ADEPT4
Enrollment
12
Registered
2012-10-18
Start date
2012-12-31
Completion date
2013-11-30
Last updated
2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Health Status Disparities, Minority Health, Pediatrics, Behavioral Intervention, Cellular Phone, Peer Group

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.

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.

BEHAVIORALMobile 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.

BEHAVIORALInhaled 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.

BEHAVIORALBeta2-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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
GlaxoSmithKline
CollaboratorINDUSTRY
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter10 weeksAdherence 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

MeasureTime frameDescription
To understand patterns of use of quick-relief medication for asthma10 weeksThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026