NCT01099800

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

June 23, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2014

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

4.2 years

First QC Date

April 6, 2010

Last Update Submit

March 5, 2020

Conditions

Keywords

asthmahealth disparitiesillness representationsCAMLatino

Outcome Measures

Primary Outcomes (1)

  • asthma control

    Level of asthma control will be assessed per NAEPP guidelines which incorporate a structured assessment of symptoms and spirometry.

    basline, 3,6,9, and 12 months

Study Arms (2)

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.

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • parents who do not have primary or equal responsibility for the child's asthma mangement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arizona State University College of Nursing and Health Innovation

Phoenix, Arizona, 85004, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Scottsdale Healthcare NOAH Clinic

Scottsdale, Arizona, 85251, United States

Location

Yeshiva University

The Bronx, New York, 10033, United States

Location

Related Publications (2)

  • Arcoleo K, Marsiglia F, Serebrisky D, Rodriguez J, Mcgovern C, Feldman J. Explanatory Model for Asthma Disparities in Latino Children: Results from the Latino Childhood Asthma Project. Ann Behav Med. 2020 Mar 24;54(4):223-236. doi: 10.1093/abm/kaz041.

  • Arcoleo KJ, McGovern C, Kaur K, Halterman JS, Mammen J, Crean H, Rastogi D, Feldman JM. Longitudinal Patterns of Mexican and Puerto Rican Children's Asthma Controller Medication Adherence and Acute Healthcare Use. Ann Am Thorac Soc. 2019 Jun;16(6):715-723. doi: 10.1513/AnnalsATS.201807-462OC.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Kimberly J Sidora-Arcoleo, PhD, MPH

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2010

First Posted

April 8, 2010

Study Start

June 23, 2010

Primary Completion

August 25, 2014

Study Completion

August 25, 2014

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations