Promoting Asthma Wellness in Rural Communities

January 29, 2015 updated by: Martha Tingen, Augusta University

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:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • 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.
Behavioral: General Asthma Education
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline, end of treatment, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
baseline, end of treatment, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

University of Michigan
Henry Ford Health System

Investigators

  • Principal Investigator: Martha S Tingen, PhD, Augusta University
  • Principal Investigator: Dennis R Ownby, MD, Augusta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL092412 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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