NCT00201058

Brief Summary

The purpose of this project is to refine and further evaluate an online asthma management and education program for urban teenagers. This project is a continuation of Puff City I, a project piloting and evaluating a tailored, school-based, computerized asthma education program for urban teenagers. In this second phase of research, a new version of software (Puff City II) will be created that will target resistance to change and relapse, and using a tested, theory-based approach to student recruitment, conduct a randomized trial to test the efficacy of this new software.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jul 2006

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

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

3.9 years

First QC Date

September 16, 2005

Last Update Submit

December 18, 2012

Conditions

Asthma

Keywords

urbanadolescentsAfrican Americanweb-basedcomputer tailoringschool based

Outcome Measures

Primary Outcomes (1)

  • Asthma-related morbidity

    Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

Secondary Outcomes (4)

  • Symptom-days

    Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

  • Symptom-nights

    Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

  • School days missed

    Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

  • Days of restricted activity

    Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

Study Arms (2)

1

EXPERIMENTAL

Receives tailored web-based program

Behavioral: Tailored Web-based Asthma Management

2

ACTIVE COMPARATOR

Control students receive existing web-based, generic asthma education

Behavioral: Generic web-based asthma education

Interventions

Tailored Web-based Asthma ManagementBEHAVIORAL

Web-based asthma management

1
Generic web-based asthma educationBEHAVIORAL

4 computer sessions over a period of 180 days

2

Eligibility Criteria

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

You may qualify if:

  • A physician diagnosis of asthma AND recent asthma symptoms, health care utilization for asthma, and/or use of medication (or refills of medication) to alleviate asthma symptoms OR
  • No physician diagnosis of asthma AND positive responses to items selected from the International Study of Asthma and Allergy in Children (ISAAC) survey AND asthma symptoms similar to those used in the Expert Panel II for classification of mild intermittent asthma

You may not qualify if:

  • Does not meet asthma symptom criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (10)

  • Joseph CL, Havstad S, Johnson CC, Vinuya R, Ownby DR. Agreement between teenager and caregiver responses to questions about teenager's asthma. J Asthma. 2006 Mar;43(2):119-24. doi: 10.1080/02770900500498246.

    PMID: 16517427BACKGROUND

  • Joseph CL, Havstad S, Anderson EW, Brown R, Johnson CC, Clark NM. Effect of asthma intervention on children with undiagnosed asthma. J Pediatr. 2005 Jan;146(1):96-104. doi: 10.1016/j.jpeds.2004.09.001.

    PMID: 15644831BACKGROUND

  • Joseph CL, Williams LK, Ownby DR, Saltzgaber J, Johnson CC. Applying epidemiologic concepts of primary, secondary, and tertiary prevention to the elimination of racial disparities in asthma. J Allergy Clin Immunol. 2006 Feb;117(2):233-40; quiz 241-2. doi: 10.1016/j.jaci.2005.11.004.

    PMID: 16461121BACKGROUND

  • Joseph CL, Baptist AP, Stringer S, Havstad S, Ownby DR, Johnson CC, Williams LK, Peterson EL. Identifying students with self-report of asthma and respiratory symptoms in an urban, high school setting. J Urban Health. 2007 Jan;84(1):60-9. doi: 10.1007/s11524-006-9121-y.

    PMID: 17200800RESULT

  • Joseph CL, Peterson E, Havstad S, Johnson CC, Hoerauf S, Stringer S, Gibson-Scipio W, Ownby DR, Elston-Lafata J, Pallonen U, Strecher V; Asthma in Adolescents Research Team. A web-based, tailored asthma management program for urban African-American high school students. Am J Respir Crit Care Med. 2007 May 1;175(9):888-95. doi: 10.1164/rccm.200608-1244OC. Epub 2007 Feb 8.

    PMID: 17290041RESULT

  • Joseph CL, Havstad SL, Ownby DR, Zoratti E, Peterson EL, Stringer S, Johnson CC. Gender differences in the association of overweight and asthma morbidity among urban adolescents with asthma. Pediatr Allergy Immunol. 2009 Jun;20(4):362-9. doi: 10.1111/j.1399-3038.2008.00803.x. Epub 2008 Sep 22.

    PMID: 18823359RESULT

  • Ezell JM, Saltzgaber J, Peterson E, Joseph CL. Reconnecting with urban youth enrolled in a randomized controlled trial and overdue for a 12-month follow-up survey. Clin Trials. 2013 Oct;10(5):775-82. doi: 10.1177/1740774513498320. Epub 2013 Aug 27.

    PMID: 23983157DERIVED

  • Joseph CL, Ownby DR, Havstad SL, Saltzgaber J, Considine S, Johnson D, Peterson E, Alexander G, Lu M, Gibson-Scipio W, Johnson CC; Research team members. Evaluation of a web-based asthma management intervention program for urban teenagers: reaching the hard to reach. J Adolesc Health. 2013 Apr;52(4):419-26. doi: 10.1016/j.jadohealth.2012.07.009. Epub 2012 Sep 27.

    PMID: 23299008DERIVED

  • Guglani L, Havstad SL, Johnson CC, Ownby DR, Joseph CL. Effect of depressive symptoms on asthma intervention in urban teens. Ann Allergy Asthma Immunol. 2012 Oct;109(4):237-242.e2. doi: 10.1016/j.anai.2012.07.010. Epub 2012 Aug 15.

    PMID: 23010228DERIVED

  • Joseph CL, Saltzgaber J, Havstad SL, Johnson CC, Johnson D, Peterson EL, Alexander G, Couper MP, Ownby DR. Comparison of early-, late-, and non-participants in a school-based asthma management program for urban high school students. Trials. 2011 Jun 6;12:141. doi: 10.1186/1745-6215-12-141.

    PMID: 21645394DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christine Joseph, PhD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

July 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

US(1)