Using Mobile Phones to Improve Adherence to Inhaled Steroids (ADEPT4)

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Giselle Mosnaim, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01710059
First received: October 16, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Asthma Supervision
Behavioral: Mobile Phone
Behavioral: Inhaled Corticosteroid Mobile Phone Application
Behavioral: Beta2-adrenergic agonist Mobile Phone Application

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Refined ADEPT: Human Augmentics for Sustained Wellbeing

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • To understand patterns of use of quick-relief medication for asthma [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710059

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: Giselle S. Mosnaim, MD, MS Rush University Medical Center
  More Information

No publications provided

Responsible Party: Giselle Mosnaim, Principal Investigator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01710059     History of Changes
Other Study ID Numbers: 10010402, 5K23HL092292-04
Study First Received: October 16, 2012
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Health Status Disparities
Minority Health
Pediatrics
Behavioral Intervention
Cellular Phone
Peer Group

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Adrenergic Agents
Adrenergic Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014