Tailored Asthma Management for Urban Teens (Puff City)
18. december 2012 opdateret af: Christine Joseph, Henry Ford Health System
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
450
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Health System
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 1
Receives tailored web-based program
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Web-based asthma management
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Aktiv komparator: 2
Control students receive existing web-based, generic asthma education
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4 computer sessions over a period of 180 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Asthma-related morbidity
Tidsramme: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
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Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Symptom-days
Tidsramme: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
|
Symptom-nights
Tidsramme: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
|
School days missed
Tidsramme: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
|
Days of restricted activity
Tidsramme: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christine Joseph, PhD, Henry Ford Health System
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2006
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først indsendt
16. september 2005
Først indsendt, der opfyldte QC-kriterier
16. september 2005
Først opslået (Skøn)
20. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. december 2012
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1299 (OHSU eIRB)
- R01HL068971-04 (U.S. NIH-bevilling/kontrakt)
- R01HL068971 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Tailored Web-based Asthma Management
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University of MiamiUnited States Department of DefenseAfsluttet
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Memorial Sloan Kettering Cancer CenterAfsluttetProstatakræftForenede Stater
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Brown UniversityUniversity of California, Los Angeles; National Institute of Nursing Research... og andre samarbejdspartnereRekrutteringForebyggelseForenede Stater
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Dartmouth-Hitchcock Medical CenterPenn State UniversityTilmelding efter invitationProlaps af bækkenorganerForenede Stater
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University of MichiganAfsluttetHjertefejlForenede Stater