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Asthma Disparities in Latino Children:Acculturation,Illness Representations & CAM

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ClinicalTrials.gov Identifier: NCT01099800
Recruitment Status : Unknown
Verified June 2011 by Arizona State University.
Recruitment status was:  Enrolling by invitation
First Posted : April 8, 2010
Last Update Posted : June 23, 2011
Information provided by:

Study Description
Brief Summary:

This interdisciplinary multi-level study moves the research in asthma health disparities from descriptive studies of individual constructs and contexts to testing an integrated, multi-factorial model among Latino families and children with asthma. The investigators seek to gain a more thorough understanding of the interaction of individual characteristics, cultural and experiential factors, social-environmental context, and healthcare system factors on parents' illness representations, use of CAM and controller medications, and children's asthma health outcomes.

This will be a one-year longitudinal, multi-site (Phoenix, AZ and Bronx, NY) study among samples of Mexican (N=300) and Puerto Rican (N=300) parents and children aged 5-12 who have asthma.

Aim #1: Are there differences in illness representations between Mexican and Puerto Rican parents due to social and contextual factors (i.e., acculturation, education, parental age, poverty, child's illness duration, household members with asthma, and parent-healthcare provider relationship)?

Aim #2: Are disparities in asthma control between Mexican and Puerto Rican children due to differences in parents' treatment decisions (CAM and controller medication use) and changes in illness representations over a one year period after controlling for the effects of acculturation, social and contextual factors, environmental triggers, and advice received from others?

Condition or disease

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Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Asthma Disparities in Latino Children:Acculturation,Illness Representations & CAM
Study Start Date : July 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts

Mexican/Mexican American families
Parents and children who self-identify as being of Mexican heritage whether US-born or Mexican-born
Puerto Rican families
Parents and children who self-identify as Puerto Rican whether US-born or island-born.

Outcome Measures

Primary Outcome Measures :
  1. asthma control [ Time Frame: basline, 3,6,9, and 12 months ]
    Level of asthma control will be assessed per NAEPP guidelines which incorporate a structured assessment of symptoms and spirometry.

Eligibility Criteria

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
To ensure diverse representation of Latino families and healthcare settings, the sample will be recruited from two school-based health clinics and one clinical practice site in Phoenix, AZ, and two inner-city hospital asthma clinics in the Bronx, NY. Approximately 300 families will be recruited and enrolled from the asthma/allergy and general pediatric clinics and ER at Jacobi Medical Center and North Central Bronx Hospital (N= 150), Phoenix Children's Hospital Breathmobile (N= 75), and the two school-based health clinics in Phoenix (N= 75).

Inclusion Criteria:

  • child must be between 5 and 12 years of age,
  • have a diagnosis of asthma as obtained from the child's medical record,
  • the family is Latino (English or Spanish speaking) as self-identified by the primary caregiver,
  • the child has no other significant pulmonary conditions (e.g., cystic fibrosis),
  • the participating parent has primary or at least equal responsibility for the day-to-day management of the child's asthma, and
  • no cognitive learning disability that could interfere with the parent's or child's (as determined by parents' report) ability to comprehend the interview questions.

Exclusion Criteria:

  • children not meeting the above inclusion criteria
  • parents who do not have primary or equal responsibility for the child's asthma mangement
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099800

United States, Arizona
Arizona State University College of Nursing and Health Innovation
Phoenix, Arizona, United States, 85004
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Scottsdale Healthcare NOAH Clinic
Scottsdale, Arizona, United States, 85251
United States, New York
Yeshiva University
Bronx, New York, United States, 10033
Sponsors and Collaborators
Arizona State University
National Center for Complementary and Integrative Health (NCCIH)
Phoenix Children's Hospital
Scottsdale Healthcare
Albert Einstein College of Medicine, Inc.
Principal Investigator: Kimberly J Sidora-Arcoleo, PhD, MPH Arizona State University
More Information

Responsible Party: Kimberly Sidora-Arcoleo, PhD, MPH, Principal Investigator, Arizona State University
ClinicalTrials.gov Identifier: NCT01099800     History of Changes
Other Study ID Numbers: 1R01AT005216-01 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Arizona State University:
health disparities
illness representations

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases