NCT01170676

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:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

May 12, 2010

Last Update Submit

January 29, 2015

Conditions

Keywords

asthmasmokingteens

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    baseline, end of treatment, 6 months, 12 months

Study Arms (2)

Puff City GA

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.

Behavioral: Puff City GA

General Asthma Education

ACTIVE COMPARATOR

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

Behavioral: General Asthma Education

Interventions

Puff City GABEHAVIORAL

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.

Also known as: Behavioral Puff City Ga.
Puff City GA

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

General Asthma Education

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Not meeting the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AsthmaSmoking

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavior

Study Officials

  • Martha S Tingen, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR
  • Dennis R Ownby, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2010

First Posted

July 27, 2010

Study Start

August 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2014

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations