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Promoting Asthma Wellness in Rural Communities

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Puff City GA
General Asthma Education
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, smoking, teens

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Georgia Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Puff City GA

General Asthma Education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Days of asthma symptoms; personal cigarette smoking and cessation; and days of school missed because of asthma, measured by self report

Secondary Outcome Measures

Change in exhaled nitric oxide and active and passive smoke exposure, measured by salivary cotinine.

Full Information

First Posted
May 12, 2010
Last Updated
January 29, 2015
Sponsor
Augusta University
Collaborators
Henry Ford Health System, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01170676
Brief Title
Promoting Asthma Wellness in Rural Communities
Official Title
Promoting Asthma Wellness in Rural Communities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
Collaborators
Henry Ford Health System, University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, smoking, teens

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Puff City GA
Arm Type
Experimental
Arm Description
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.
Arm Title
General Asthma Education
Arm Type
Active Comparator
Arm Description
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.
Intervention Type
Behavioral
Intervention Name(s)
Puff City GA
Other Intervention Name(s)
Behavioral Puff City Ga.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General Asthma Education
Intervention Description
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha S Tingen, PhD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis R Ownby, MD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Health Sciences University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29984589
Citation
Jordan DM, Bush JS, Ownby DR, Waller JL, Tingen MS. The impact of traditional literacy and education on health literacy in adolescents with asthma. J Asthma. 2019 Aug;56(8):882-890. doi: 10.1080/02770903.2018.1494191. Epub 2018 Sep 5.
Results Reference
derived

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Promoting Asthma Wellness in Rural Communities

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