- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01783028
Home-Based Asthma Support and Education for Adults (HomeBase)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Washington
-
Seattle, Washington, Verenigde Staten, 98104
- Public Health - Seattle & King County
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
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.
Andere namen:
|
|
Geen tussenkomst: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
asthma symptom-free days during the last two weeks
Tijdsspanne: baseline and 12 months after enrollment
|
Asthma symptoms are evaluated using the following questions:
|
baseline and 12 months after enrollment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Asthma-related quality of life score during the last two weeks
Tijdsspanne: baseline and 12 months after enrollment
|
Asthma Quality of Life Questionnaire http://www.qoltech.co.uk/aqlq.html |
baseline and 12 months after enrollment
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
health care utilization
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: James Krieger, MD, Public Health - Seattle and King County
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PHSKC-AST-HomeBASE
- 1R01ES014583-01A1 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .