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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 January 2013
Main ID:  NCT01251523
Date of registration: 01/12/2010
Primary sponsor: University of Michigan
Public title: Improving Asthma Outcomes Through Cultural Competence Training for Physicians
Scientific title: Improving Asthma Outcomes Through Cultural Competence Training for Physicians
Date of first enrolment: November 2010
Target sample size: 1282
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01251523
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care  
Countries of recruitment
United States
Contacts
Name:   Lara J Thomas, MPH
Address: 
Telephone: 734-615-3253
Email: ljthomas@umich.edu
Affiliation: 
Name:   Noreen M Clark, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Michigan School of Public Health
Key inclusion & exclusion criteria

Inclusion Criteria:

- Physician enrollment criteria are: 1) licensed physician in practice and board
certified in pediatrics or family medicine; 2) treating children with asthma; 3)
full-time in a practice in Atlanta, GA or New York City, NY; 4) not Latino/Hispanic
or African American in ethnicity/race; 5) consenting to participate and 6) will
generate a roster of pediatric asthma patients.

The following patient selection criteria will be used.

- The child must: 1) be treated by the participating physician during the study intake
period; 2) be between one and 16 years of age; 3) have a diagnosis of asthma made by
a physician using the NAEPP Guidelines for the diagnosis of asthma (NHLBI, 2007) (The
investigators will not accept alternative descriptions such as reactive airway
disease, bronchitis, or wheezy bronchitis. The determination must be asthma); 4)
have at least one emergency medical care visit in the previous year (hospitalization,
or ED or physician office visit on an emergency basis defined as administration of
epinephrine sub-cutaneously or bronchodilators by aerosol); 5) not have other chronic
disorders that have pulmonary complications, e.g. sickle cell disease; 6) be of
self-identified African American or Latino/Hispanic race/ethnicity.

- In addition, the parent/caretaker must meet the following criteria: 1) be the one
usually responsible for the child's car; 2) be of self identified African American or
Latino/Hispanic race/ethnicity; 3) have access to a telephone; and 4) consent to
participate.

Exclusion Criteria:

- Physicians and patients who cannot meet the above inclusion criteria



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Asthma
Intervention(s)
Behavioral: PACE
Behavioral: PACE Plus
Primary Outcome(s)
Emergency Department Visits - 1st time point [Time Frame: 12 months prior to baseline interview]
Emergency Department Visits - 2nd time point [Time Frame: Interval between baseline and 12 months]
Emergency Department Visits - 3rd time point [Time Frame: interval between 12 month and 24 month telephone interview]
Secondary Outcome(s)
Hospitalizations - 2nd time point [Time Frame: Interval between baseline and 12 month telephone interview]
Hospitalizations - 3rd time point [Time Frame: interval between 12 month and 24 month telephone interview]
Hospitalizations - first time point [Time Frame: Year prior to baseline interview]
Secondary ID(s)
1R01HL09338601A2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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