Reducing Asthma Morbidity In High Risk Minority Preschool Children (ABC-HS)

This study is currently recruiting participants.
Verified January 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Cynthia Rand, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01519453
First received: January 24, 2012
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

Despite advances in asthma therapies and the wide-spread dissemination of asthma clinical guidelines, low-income, minority children have disproportionately high morbidity and mortality from asthma. The National Center for Children in Poverty has strongly argued that effective interventions to improve asthma health disparities and reduce harm must begin in early childhood. Previous efficacy studies have suggested that asthma education programs can be effective in improving overall management of asthma for preschool children. However, for these promising asthma intervention strategies to have sustainable public health impact for low-income, minority children they must be integrated within those medical, educational and social structures that serve these young high risk children, such as community clinics, schools and day care programs. Because one of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students, Head Start represents an ideal community setting for disseminating early asthma education. The investigators propose to draw on our established health and research partnership with Head Start programs in Baltimore City to test the effectiveness of this home-based asthma education intervention with demonstrated efficacy, when delivered in the context of a Head Start-wide asthma education program. The investigators further propose to partner with Head Start to support and evaluate adoption, maintenance and dissemination of new knowledge gained from this project. Specifically the investigators hypothesize that participants receiving the ABC intervention combined with a HS-level asthma education will have more symptom free days at the 6-, 9-, and 12-month evaluation when compared with participants in the HS-level asthma education alone. The investigators plan to enroll of 406 children age 2-6 years old enrolled in Head Start with symptomatic asthma. Secondary outcome measures include other measures of asthma morbidity (i.e., hospitalizations, ED visits, oral steroid bursts, school absences, and caregiver quality of life). The investigators will also evaluate the mediating effects of outcomes expectancies, self-efficacy, asthma knowledge, motivation, and asthma management practices, as well as moderator effects, such as health literacy, caregiver depression, neighborhood cohesion, family management of asthma, and Head Start adoption and dissemination of an asthma education curriculum.


Condition Intervention Phase
Asthma
Behavioral: Home Based Asthma Education
Phase 3

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: Reducing Asthma Morbidity In High Risk Minority Preschool Children

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Symptom Free days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Number of days within the past 30 days the child reports not having asthma symtoms


Secondary Outcome Measures:
  • ED visits [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of ED visits for asthma in past 30 days

  • Hospitalizations [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of hospitalizations in last 3 months due to asthma


Estimated Enrollment: 406
Study Start Date: September 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home Based Asthma Education
Families will receive 4 home and 3 phone asthma education sessions with a community asthma outreach worker
Behavioral: Home Based Asthma Education
4 home and 3 phone sessions with community asthma outreach worker to provide families with asthma education
No Intervention: Control

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in Head Start
  • Physician diagnosed asthma or reactive airway disease
  • resides in Baltimore City
  • English Speaking
  • Asthma symptoms on 4 days/nights in the last four weeks or use of albuterol one time in the last week or ED visit in the last 6 months

Exclusion Criteria:

  • Enrolled in another pulmonary research study
  • sibling enrolled in study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519453

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Michelle Eakin, Ph.D.    410-550-0487    meakin1@jhmi.edu   
Principal Investigator: Cynthia Rand, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Cynthia Rand, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Cynthia Rand, Ph.D., Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01519453     History of Changes
Other Study ID Numbers: HL-107223
Study First Received: January 24, 2012
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Asthma
Preschool
Health Disparities
Implementation

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 April 15, 2014