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

8. mai 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

366

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Public Health - Seattle & King County

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Atferdsmessig: 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 navn:
  • CHW intervention
Ingen inngripen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Public Health - Seattle and King County

Samarbeidspartnere

National Institute of Environmental Health Sciences (NIEHS)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2008

Primær fullføring (Faktiske)

1. november 2011

Studiet fullført (Faktiske)

1. november 2011

Datoer for studieregistrering

Først innsendt

31. januar 2013

Først innsendt som oppfylte QC-kriteriene

31. januar 2013

Først lagt ut (Anslag)

4. februar 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. mai 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2014

Sist bekreftet

1. mai 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PHSKC-AST-HomeBASE
  • 1R01ES014583-01A1 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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