The Community United to Challenge Asthma

Asthma Clinical Trial

— Project CURA  

Official title:

A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065883
• Other study ID #: 1R21HL093346-01A1
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: August 13, 2012
• Start date: October 2009
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• community health worker
community health workers will provide education in the home
• mailed information
information will be mailed to the home on the same schedule as the experimental intervention

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asthma medication adherence		before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)	No
Secondary	asthma trigger reduction		before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)	No