The Community United to Challenge Asthma (Project CURA)
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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 |
- asthma medication adherence [ Time Frame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance) ] [ Designated as safety issue: No ]
- 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 |
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 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013