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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
  Purpose

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.

Condition Intervention
Asthma
 Behavioral: Puff City GA
Behavioral: General Asthma Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Asthma Wellness in Rural Communities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: General Asthma Education

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.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170676

Locations
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Henry Ford Health System
University of Michigan
Investigators
Principal Investigator: Martha S Tingen, PhD Georgia Regents University
Principal Investigator: Dennis R Ownby, MD Georgia Regents University
  More Information

No publications provided

Responsible Party: Martha Tingen, Professor, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01170676     History of Changes
Other Study ID Numbers: R01HL092412
Study First Received: May 12, 2010
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
asthma
smoking
teens

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013