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

8 maj 2014 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

366

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Public Health - Seattle & King County

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Beteende: 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.
Andra namn:
  • CHW intervention
Inget ingripande: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
asthma symptom-free days during the last two weeks
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Asthma-related quality of life score during the last two weeks
Tidsram: baseline and 12 months after enrollment

Asthma Quality of Life Questionnaire

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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
health care utilization
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Public Health - Seattle and King County

Samarbetspartners

National Institute of Environmental Health Sciences (NIEHS)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2008

Primärt slutförande (Faktisk)

1 november 2011

Avslutad studie (Faktisk)

1 november 2011

Studieregistreringsdatum

Först inskickad

31 januari 2013

Först inskickad som uppfyllde QC-kriterierna

31 januari 2013

Första postat (Uppskatta)

4 februari 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

12 maj 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 maj 2014

Senast verifierad

1 maj 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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