NCT01061424

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 in high-risk Puerto Rican children in elementary school. The primary outcomes are asthma medication adherence and trigger reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

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
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

2.7 years

First QC Date

February 1, 2010

Last Update Submit

August 13, 2012

Conditions

Keywords

pediatric asthma

Outcome Measures

Primary Outcomes (1)

  • medication adherence

    1 year

Secondary Outcomes (1)

  • trigger reduction

    1 year

Study Arms (2)

mailed information

ACTIVE COMPARATOR

information on asthma is mailed to the home on the same schedule as the other arm

Behavioral: mailed information

community health worker

EXPERIMENTAL

community health worker provides home visits for education

Behavioral: community health worker

Interventions

community health worker provides home visits for education

community health worker

information on asthma is mailed to the home on the same schedule as the other arm

mailed information

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Puerto Rican
  • In elementary school
  • Diagnosed with asthma

You may not qualify if:

  • Not in school
  • Mild intermittent asthma
  • Well 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.

  • 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.

  • 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.

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 Officials

  • Molly A Martin, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

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 3, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations