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The Community United to Challenge Asthma (Project CURA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065883
First Posted: February 9, 2010
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Molly A. Martin, MD, Rush University Medical Center
  Purpose
This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education on two risk factors for asthma exacerbations in high-risk Puerto Rican children in high school. The self-management intervention will be a series of home visits provided by Puerto Rican community health workers. During home visits, the family will be educated using a standard asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs. Specific Aim 1 is to test the ability of this tailored community health worker self-management intervention to reduce home asthma triggers and increase medication adherence in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers and adherence associated with this intervention are sustained 8 months after the completion of the active intervention. Another goal of the study is to build community capacity for asthma management in the target high-risk community.

Condition Intervention
Asthma Behavioral: community health worker Behavioral: mailed information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans

Further study details as provided by Molly A. Martin, MD, Rush University Medical Center:

Primary Outcome Measures:
  • asthma medication adherence [ Time Frame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance) ]

Secondary Outcome Measures:
  • asthma trigger reduction [ Time Frame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance) ]

Enrollment: 50
Study Start Date: October 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: community health worker
community health workers will provide education in the home
Behavioral: community health worker
community health workers will provide education in the home
Active Comparator: mailed information
information will be mailed to the home on the same schedule as the experimental intervention
Behavioral: mailed information
information will be mailed to the home on the same schedule as the experimental intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Puerto Rican
  • In high school
  • Have asthma

Exclusion Criteria:

  • More than 18 years old
  • In last year of school
  • Mild intermittent or controlled asthma
  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): NCT01065883


Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Molly A. Martin, MD, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01065883     History of Changes
Other Study ID Numbers: 1R21HL093346-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 1, 2010
First Posted: February 9, 2010
Last Update Posted: August 15, 2012
Last Verified: August 2012

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