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

This study is not yet open for participant recruitment.

Verified October 2012 by Rush University Medical Center

Sponsor:

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

GlaxoSmithKline

Information provided by (Responsible Party):

Giselle Mosnaim, Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT01710059

First received: October 16, 2012

Last updated: NA

Last verified: October 2012

History: No changes posted

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: Coping Peer Support Behavioral: Coping Peer Asthma Messages Behavioral: Asthma Supervision Behavioral: Music Tracks 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:

MedlinePlus related topics: Asthma Steroids

U.S. FDA Resources

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.

Estimated Enrollment:	20
Study Start Date:	December 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental: Intervention Group Experimental: Intervention Group 1) Coping Peer Support delivered over a 10-week time period; 2) Coping Peer Asthma Messages delivered over a 10-week time period; 3) Asthma Supervision; 4) Music Tracks; 5) Mobile Phone with talking, texting, and data plan; 6) Inhaled Corticosteroid Mobile Phone Application to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated; and 7) Beta2-adrenergic agonist Mobile Phone Application to monitor real time patterns of use of beta2-adrenergic agonist medication for asthma.	Behavioral: Coping Peer Support Coping Peer Support will be delivered at weekly group sessions over the 10-week active treatment period. This intervention consists of: group support, group problem solving, and recording of Coping Peer Asthma Messages. Behavioral: Coping Peer Asthma Messages Study participants will develop and record Coping Peer Asthma Messages at their weekly Coping Peer Group asthma meetings during the 10-week active treatment period. These Coping Peer Asthma Messages will be placed on the participants' mobile phones, and played between their favorite music tracks, as they go about their daily routines. This brings the Coping Peer Support from the weekly Coping Peer Support sessions into their daily lives. 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. Behavioral: Music Tracks Study participants receive clean (radio-edited) music tracks during the 10-week active treatment period. 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.

Arms

Assigned Interventions

Experimental: Experimental: Intervention Group

Experimental: Intervention Group

1) Coping Peer Support delivered over a 10-week time period; 2) Coping Peer Asthma Messages delivered over a 10-week time period; 3) Asthma Supervision; 4) Music Tracks; 5) Mobile Phone with talking, texting, and data plan; 6) Inhaled Corticosteroid Mobile Phone Application to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated; and 7) Beta2-adrenergic agonist Mobile Phone Application to monitor real time patterns of use of beta2-adrenergic agonist medication for asthma.

Behavioral: Coping Peer Support

Coping Peer Support will be delivered at weekly group sessions over the 10-week active treatment period. This intervention consists of: group support, group problem solving, and recording of Coping Peer Asthma Messages.

Behavioral: Coping Peer Asthma Messages

Study participants will develop and record Coping Peer Asthma Messages at their weekly Coping Peer Group asthma meetings during the 10-week active treatment period. These Coping Peer Asthma Messages will be placed on the participants' mobile phones, and played between their favorite music tracks, as they go about their daily routines. This brings the Coping Peer Support from the weekly Coping Peer Support sessions into their daily lives.

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.

Behavioral: Music Tracks

Study participants receive clean (radio-edited) music tracks during the 10-week active treatment period.

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

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

Contacts

Contact: Giselle S. Mosnaim, MD, MS

312-942-8571

gmosnaim@rush.edu

Locations

United States, Illinois
Rush University Medical Center	Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Giselle S. Mosnaim, MD, MS 312-942-8571 gmosnaim@rush.edu
Principal Investigator: Giselle S. Mosnaim, MD, MS

Sponsors and Collaborators

Rush University Medical Center

National Heart, Lung, and Blood Institute (NHLBI)

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:	October 16, 2012
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 May 23, 2013

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