NCT01065883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

2.4 years

First QC Date

February 1, 2010

Last Update Submit

August 13, 2012

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • asthma medication adherence

    before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)

Secondary Outcomes (1)

  • asthma trigger reduction

    before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)

Study Arms (2)

community health worker

EXPERIMENTAL

community health workers will provide education in the home

Behavioral: community health worker

mailed information

ACTIVE COMPARATOR

information will be mailed to the home on the same schedule as the experimental intervention

Behavioral: mailed information

Interventions

community health workerBEHAVIORAL

community health workers will provide education in the home

community health worker
mailed informationBEHAVIORAL

information will be mailed to the home on the same schedule as the experimental intervention

mailed information

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Puerto Rican
  • In high school
  • Have asthma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • Martin MA, Mosnaim GS, Olson D, Swider S, Karavolos K, Rothschild S. Results from a community-based trial testing a community health worker asthma intervention in Puerto Rican youth in Chicago. J Asthma. 2015 Feb;52(1):59-70. doi: 10.3109/02770903.2014.950426. Epub 2014 Aug 27.

    PMID: 25162304DERIVED

  • Martin MA, Thomas AM, Mosnaim G, Greve M, Swider SM, Rothschild SK. Home asthma triggers: barriers to asthma control in Chicago Puerto Rican children. J Health Care Poor Underserved. 2013 May;24(2):813-27. doi: 10.1353/hpu.2013.0073.

    PMID: 23728047DERIVED

  • Martin MA, Olson D, Mosnaim G, Ortega D, Rothschild SK. Recruitment, asthma characteristics, and medication behaviors in Midwestern Puerto Rican youth: data from Project CURA. Ann Allergy Asthma Immunol. 2012 Aug;109(2):121-7. doi: 10.1016/j.anai.2012.06.005. Epub 2012 Jun 26.

    PMID: 22840253DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 9, 2010

Study Start

October 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

US(1)