- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00014820
Occupation and Asthma in an Urban Low Income Population
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
BACKGROUND:
Work-related asthma is asthma that is attributable to, or is made worse by, environmental exposures in the workplace. Published estimates of the proportion of adult asthma attributable to occupational factors have varied widely, depending on population, methodology, and definitions, from 2 percent to 33 percent. Occupational asthma is of great public health importance because it is potentially preventable, can cause substantial disability, and in some cases is completely curable. Among adults in the United States, asthma has become a major public health problem, with rates most elevated among low income, urban, African American and Latino sectors of the population, and with substantial evidence suggesting potential occupational contributions to the excess rates. These important sectors of the U.S. population have, however, been inadequately represented in the occupational asthma research literature.
DESIGN NARRATIVE:
This was a case control study of physician-diagnosed asthma, occupation, industry, and workplace environmental exposures designed to evaluate the hypothesis that a substantial component of the asthma burden in a low income, urban, largely minority population was due to occupational factors. The study design addressed a variety of methodologic challenges including healthy worker effects, difficulty contacting and recruiting this potentially high risk population, large numbers of potential etiologic agents, mixed exposures, small workplaces, and low absolute incidence of occupational asthma.
The study population was the catchment population of Bellevue Hospital, a general hospital in lower Manhattan, New York City, with busy ambulatory care services that serve low income working communities. Cases and controls were recruited from among outpatients and inpatients at Bellevue Hospital and interviewed face-to-face or by telephone. Occupation, industry, and occupational exposures were determined by questionnaire supplemented by a Job Exposure Matrix. Odds ratios (ORs) of association between asthma and specific industrial, occupational, and exposure categories, controlled for major confounders, were estimated. The ORs were used to calculate occupation- and industry-specific Attributable Fractions, and an overall Population Attributable Fraction of asthma attributable to occupational factors. New onset occupational asthma and work-aggravated asthma were investigated separately.
Studientyp
Einschreibung (Tatsächlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Exclusion criteria:
- Subject unwilling to be interviewed or does not give informed consent
- For nonsmokers, age under 18 or over 65. For smokers, age under 18 or over 45
- For cases, asthma diagnosis (at Bellevue or elsewhere) prior to beginning of study period. For controls, asthma diagnosis ever.
- Unemployed at case onset age
- Fee-coded as Medicaid for all visits during study period
- Fluency in either English or Spanish inadequate to communicate clearly with interviewer, or need for interpreter in language other than Spanish noted in chart
- Medical records not HIV disease, STD, addiction-related diagnosis, or other "sensitive" diagnosis (to avoid problems of confidentiality)
- Clear understanding of what is being asked is lacking, in judgement of interviewer
- Responses to initial interview questions appear grossly unreliable, in the judgement of the interviewer
- Prisoners
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Fallkontrolle
- Zeitperspektiven: Retrospektive
Kohorten und Interventionen
Gruppe / Kohorte |
---|
Patients with a diagnosis of asthma (new) (Cases)
Patients with a physician diagnosis of asthma during the 7.5 years being studied who were working at the time of diagnosis, as determined by patient interviews.
|
Patients with a diagnosis other than asthma (Controls)
Patients (age-matched to a case patient) with a physician diagnosis other than asthma who were working at the time of diagnosis.
|
Patients with a diagnosis of asthma (previous)
Patients with a physician diagnosis of asthma prior to the 7.5 years being studied
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: George Friedman-Jimenez, NYU Langone Health
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 7953
- R01HL062621 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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