Promoting Asthma Wellness in Rural Communities

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Henry Ford Health System

University of Michigan

Information provided by (Responsible Party):

Martha Tingen, Georgia Health Sciences University

ClinicalTrials.gov Identifier:

NCT01170676

First received: May 12, 2010

Last updated: November 20, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 12, 2010

Last Updated Date

November 20, 2012

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Days of asthma symptoms; personal cigarette smoking and cessation; and days of school missed because of asthma, measured by self report [ Time Frame: baseline, end of treatment, 6 months, 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01170676 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in exhaled nitric oxide and active and passive smoke exposure, measured by salivary cotinine. [ Time Frame: baseline, end of treatment, 6 months, 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Promoting Asthma Wellness in Rural Communities

Official Title ^ICMJE

Promoting Asthma Wellness in Rural Communities

Brief Summary

This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth:

Improving adherence to asthma controller medication use;
Improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms;
Improving inhaler technique;
Smoking reduction or cessation in those who are smokers; and
Avoidance of second-hand smoke exposure.

Detailed Description

A randomized control trial across three southeastern rural high schools comparing a web-based tailored intervention (known as Puff City) to web-based traditional control education sites.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Behavioral: Puff City GA
Puff City GA focuses on three areas of health behavior: 1) adherence to controller medications; 2) immediate availability of rescue medication; 3)smoking cessation/reduction.

Other Name: Behavioral Puff City Ga.
Behavioral: General Asthma Education
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.

Other Name: General Asthma Education

Study Arm (s)

Experimental: Puff City GA
Puff City is an NHLBI-funded (C. Joseph, PI; Henry Ford Health System, Detroit, MI), web-based intervention that targets three key asthma management issues in youth: 1) smoking reduction or cessation in those who are smokers, 2) improving adherence to asthma controller medication use, and 3) improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms. Puff City Ga. is a replication study in the rural southeastern United States that adds biological assessments in addition to self-report data.

Intervention: Behavioral: Puff City GA
Active Comparator: General Asthma Education
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.

Intervention: Behavioral: General Asthma Education

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

May 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

AA ethnicity
in 9th - 11th grade of selected rural schools
have an asthma diagnosis and/or asthma-like symptoms by screening eligible on the Lung Health Survey
have access to a telephone or mobile phone
being the parent of a student meeting the above criteria with whom the student resides the majority of the time.

Exclusion Criteria:

Not meeting the above criteria.

Gender

Both

Ages

14 Years to 21 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01170676

Other Study ID Numbers ^ICMJE

R01HL092412

Has Data Monitoring Committee

Yes

Responsible Party

Martha Tingen, Georgia Health Sciences University

Study Sponsor ^ICMJE

Georgia Regents University

Collaborators ^ICMJE

Henry Ford Health System
University of Michigan

Investigators ^ICMJE

Principal Investigator:	Martha S Tingen, PhD	Georgia Regents University
Principal Investigator:	Dennis R Ownby, MD	Georgia Regents University

Information Provided By

Georgia Regents University

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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