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
  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:


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
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: 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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014