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Home-Based Asthma Support and Education for Adults (HomeBase)

8. maj 2014 opdateret af: James Krieger, Public Health - Seattle and King County
This study tests the hypothesis that community health workers providing home visits to provide education and support for self-management of asthma, assessment of the home for environmental triggers, resources for asthma control, and assistance in effective communication with medical providers over the course of one year would reduce asthma morbidity, asthma-related urgent health care use and exposure to indoor asthma triggers among low income adults with not well controlled asthma.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We used a randomized controlled parallel group design to compare the intervention to a usual-care control group. We attempted to evaluate the effectiveness of the intervention in the "real world," rather than its ideal efficacy.

The CHWs used protocols that specified education content, participant skill development and participant and CHW actions. The CHWs modified their approach to meet the priorities of participants using motivational interviewing techniques. They addressed asthma patho-physiology, reliever and controller medication use, self-monitoring, use of an asthma action plan, environmental assessment, trigger avoidance, effective use of the health care system, successful communication with health care providers, and weight control (obesity is associated with increased asthma symptoms). Participants also received low-literacy educational materials, in English or Spanish. The education concepts and environmental assessment activities were based on our prior healthy homes work modified for adults.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

366

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Public Health - Seattle & King County

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • residence of King County Washington
  • household income below the 250% of the 2007 federal poverty level
  • had "not well controlled asthma" or "very poorly controlled asthma"

Exclusion Criteria:

  • speak a language other than English or Spanish
  • no permanent housing

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
Eksperimentel: Community Health Worker support
home visits from community health workers providing education and support for self-management of asthma, assessment of the home for environmental triggers, resources for asthma control, and assistance in effective communication with medical providers
Adfærdsmæssigt: Community Health Worker support
For the intervention group, a trained Community Health Worker (CHW) provided education, support and service coordination through home visits. The CHW first made an in home assessment visit. At the assessment visit, the participant had the opportunity to ask questions and sign written consent. During this visit, the CHW assessed the participant's knowledge of asthma, current status of asthma control, challenges with controlling asthma, self-management practices and exposure to asthma triggers. After enrollment, the participant received up to four follow-up educational visits 0.5, 1.5, 3.5 and 7 months later. In addition to scheduled visits, the CHWs worked with their participants on an as-needed basis via telephone, email, or additional home visits.
Andre navne:
  • CHW intervention
Ingen indgriben: the usual care control group
Usual care is defined as services received by participants in the absence of the intervention plus information about community resources that support asthma self-management (such as classes and support groups) and educational pamphlets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
asthma symptom-free days during the last two weeks
Tidsramme: baseline and 12 months after enrollment

Asthma symptoms are evaluated using the following questions:

  1. During the past 14 days (that is, during the past fourteen 24 hour periods that include daytime and nighttime), on how many DAYS did you have any asthma symptoms, such as wheezing, coughing, tightness in the chest, shortness of breath, waking up at night because of asthma symptoms, or slowing down of usual activities because of asthma?
  2. During the DAYTIME in the past 14 days, how many DAYS did you have asthma symptoms, such as wheezing, cough, tightness in the chest, or shortness of breath?
  3. During the past 14 days, how many days did you have to slow down or stop your usual activities because of asthma, wheezing or tightness in the chest, or cough?
  4. During the NIGHTTIME in the past 14 nights, how many NIGHTS did you WAKE UP because of asthma, wheezing, cough, tightness in the chest, or shortness of breath?.
baseline and 12 months after enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Asthma-related quality of life score during the last two weeks
Tidsramme: baseline and 12 months after enrollment

Asthma Quality of Life Questionnaire

http://www.qoltech.co.uk/aqlq.html
baseline and 12 months after enrollment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
health care utilization
Tidsramme: baseline and 12 months after enrollment
health care utilization includes asthma-related hospitalization, emergency department visit, and unscheduled clinic visit during the past 12 months
baseline and 12 months after enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Public Health - Seattle and King County

Samarbejdspartnere

National Institute of Environmental Health Sciences (NIEHS)

Efterforskere

  • Ledende efterforsker: James Krieger, MD, Public Health - Seattle and King County

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

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. marts 2008

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. november 2011

Datoer for studieregistrering

Først indsendt

31. januar 2013

Først indsendt, der opfyldte QC-kriterier

31. januar 2013

Først opslået (Skøn)

4. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PHSKC-AST-HomeBASE
  • 1R01ES014583-01A1 (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 .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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