Overview

This trial is active, not recruiting.

Condition asthma
Treatments puff city ga, general asthma education
Sponsor Georgia Regents University
Collaborator Henry Ford Health System
Start date August 2009
End date May 2013
Trial size 300 participants
Trial identifier NCT01170676, R01HL092412

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:

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
puff city ga 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.
(Active Comparator)
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.
general asthma education General Asthma Education
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 14 years up to 21 years old.

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.

Additional Information

Official title Promoting Asthma Wellness in Rural Communities
Principal investigator Martha S Tingen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Georgia Regents University.