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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519453
First Posted: January 27, 2012
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
January 24, 2012
January 27, 2012
April 17, 2017
September 2011
November 2016   (Final data collection date for primary outcome measure)
Symptom Free days [ Time Frame: 30 days ]
Number of days within the past 30 days the child reports not having asthma symptoms
Symptom Free days [ Time Frame: 30 days ]
Number of days within the past 30 days the child reports not having asthma symtoms
Complete list of historical versions of study NCT01519453 on ClinicalTrials.gov Archive Site
  • Emergency Department (ED) visits [ Time Frame: 3 months ]
    Number of ED visits for asthma in past 30 days
  • Hospitalizations [ Time Frame: 3 months ]
    Number of hospitalizations in last 3 months due to asthma
  • ED visits [ Time Frame: 3 months ]
    Number of ED visits for asthma in past 30 days
  • Hospitalizations [ Time Frame: 3 months ]
    Number of hospitalizations in last 3 months due to asthma
Not Provided
Not Provided
 
Reducing Asthma Morbidity In High Risk Minority Preschool Children
Reducing Asthma Morbidity In High Risk Minority Preschool Children
Low-income, minority children are disproportionately affected by asthma and can experience higher rates of asthma attacks, lower lung function, decreased physical activity, increases in school absenteeism, and higher rates of death. The National Center for Children in Poverty suggests that effective interventions to improve asthma and reduce harm for high risk groups (like low-income minority children) must begin in early childhood. Previous research has shown that asthma education programs can be effective to improve overall asthma management in preschool children, but there has been limited sustainability of these programs in medical, educational, and social environments that serve young high risk children. 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 and would be an ideal setting in the community to disseminate an early asthma education program. The purpose of this study is to draw on our health and research partnership with Baltimore City Head Start programs to test the effectiveness of a home-based asthma education intervention combined with a Head Start level asthma education program compared to a Head Start level asthma education program alone.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Asthma
Behavioral: Home Based Asthma Education
4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education
  • Experimental: Home Based Asthma Education
    Families will receive 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker
    Intervention: Behavioral: Home Based Asthma Education
  • No Intervention: Control
    There is no control arm specific intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
401
December 2017
November 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrolled in Head Start
  • Physician diagnosed asthma or reactive airway disease
  • Resides in Baltimore City or Baltimore County
  • English Speaking

Exclusion Criteria:

  • Enrolled in another pulmonary research study
  • Sibling enrolled in study
Sexes Eligible for Study: All
2 Years to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01519453
HL-107223
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: We will not be sharing individual participant data with other researchers
Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Cynthia Rand, Ph.D. Johns Hopkins University
Johns Hopkins University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP