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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT01251523 |
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Date of registration:
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01/12/2010 |
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Primary sponsor: |
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Public title:
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Improving Asthma Outcomes Through Cultural Competence Training for Physicians
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Scientific title:
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Improving Asthma Outcomes Through Cultural Competence Training for Physicians |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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1282 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01251523 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Lara J Thomas, MPH |
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Address:
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Telephone:
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734-615-3253 |
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Email:
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ljthomas@umich.edu |
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Affiliation:
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Name:
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Noreen M Clark, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan School of Public Health |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Behavioral: PACE
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Behavioral: PACE Plus
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Primary Outcome(s)
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Emergency Department Visits - 1st time point
[Time Frame: 12 months prior to baseline interview]
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Emergency Department Visits - 2nd time point
[Time Frame: Interval between baseline and 12 months]
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Emergency Department Visits - 3rd time point
[Time Frame: interval between 12 month and 24 month telephone interview]
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Secondary Outcome(s)
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Hospitalizations - 2nd time point
[Time Frame: Interval between baseline and 12 month telephone interview]
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Hospitalizations - 3rd time point
[Time Frame: interval between 12 month and 24 month telephone interview]
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Hospitalizations - first time point
[Time Frame: Year prior to baseline interview]
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Secondary ID(s)
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1R01HL09338601A2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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