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The Community United to Challenge Asthma (Project CURA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molly A. Martin, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01065883
First received: February 1, 2010
Last updated: August 13, 2012
Last verified: August 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans

Further study details as provided by 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • asthma trigger reduction [ Time Frame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065883

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

No publications provided by Rush University Medical Center

Additional 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
Study First Received: February 1, 2010
Last Updated: August 13, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 23, 2014