Tailored Asthma Management for Urban Teens

NCT ID: NCT00201058

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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BACKGROUND:

Teenagers are among an age group that has seen dramatic increases in deaths from asthma. In Detroit, asthma death rates for teenagers are high relative to younger ages, despite a higher prevalence in the latter age group. Early studies suggest that inadequate asthma management plays a significant role in these grim statistics.

DESIGN NARRATIVE:

The study hypothesis is that students randomized to the intervention group will have lower asthma-related morbidity as determined by fewer emergency department visits and hospitalizations at the time of the 12-month follow-up. Based on a second hypothesis of better functional status among students randomized to the intervention group, secondary outcomes include fewer symptom-days, symptom-nights, school days missed, and days of restricted activity at the time of the 12-month follow-up. In addition, it is hypothesized that students in the intervention group will have higher scores on the Juniper Pediatric Quality of Life scale at 12 months. Finally, it is hypothesized that intervention students would exhibit positive changes in adherence behavior, having a rescue inhaler nearby, and smoking at the 12-month follow-up.

Conditions

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Asthma

Keywords

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urban adolescents African American web-based computer tailoring school based

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Receives tailored web-based program

Group Type EXPERIMENTAL

Tailored Web-based Asthma Management

Intervention Type BEHAVIORAL

Web-based asthma management

2

Control students receive existing web-based, generic asthma education

Group Type ACTIVE_COMPARATOR

Generic web-based asthma education

Intervention Type BEHAVIORAL

4 computer sessions over a period of 180 days

Interventions

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Tailored Web-based Asthma Management

Web-based asthma management

Intervention Type BEHAVIORAL

Generic web-based asthma education

4 computer sessions over a period of 180 days

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Does not meet asthma symptom criteria
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Christine Joseph

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Joseph, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16517427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15644831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16461121 (View on PubMed)

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.

Reference Type RESULT
PMID: 17200800 (View on PubMed)

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.

Reference Type RESULT
PMID: 17290041 (View on PubMed)

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.

Reference Type RESULT
PMID: 18823359 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23983157 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23299008 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23010228 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21645394 (View on PubMed)

Other Identifiers

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R01HL068971-04

Identifier Type: NIH

Identifier Source: secondary_id

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R01HL068971

Identifier Type: NIH

Identifier Source: secondary_id

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1299

Identifier Type: -

Identifier Source: org_study_id