Promoting Asthma Wellness in Rural Communities

Asthma Clinical Trial

Official title:

Promoting Asthma Wellness in Rural Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170676
• Other study ID #: R01HL092412
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: January 29, 2015
• Start date: August 2009
• Est. completion date: May 2014

Study information

• Verified date: January 2015
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: May 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 21 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• General Asthma Education
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.

Locations

Country	Name	City	State
United States	Georgia Health Sciences University	Augusta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Georgia Regents University	Henry Ford Health System, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of asthma symptoms; personal cigarette smoking and cessation; and days of school missed because of asthma, measured by self report		baseline, end of treatment, 6 months, 12 months	No
Secondary	Change in exhaled nitric oxide and active and passive smoke exposure, measured by salivary cotinine.		baseline, end of treatment, 6 months, 12 months	No