Project CURA: The Community United to Challenge Asthma

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01065883
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Asthma	Behavioral: community health worker; Behavioral: mailed information	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• 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
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. asthma medication adherence [before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)]

Secondary Outcome Measures

1. asthma trigger reduction [before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Molly A. Martin, MD, MD, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT01065883
• Other Study ID Numbers: 1R21HL093346-01A1
• First Posted: Feb 9, 2010
• Last Update Posted: Aug 15, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Aug 15, 2012