Reducing Asthma Morbidity In High Risk Minority Preschool Children

Asthma Clinical Trial

— ABC-HS  

Official title:

Reducing Asthma Morbidity in High Risk Minority Preschool Children (Asthma Basic Care (ABC) at Head Start)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519453
• Other study ID #: NA_00046455
• Secondary ID: HL-107223
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 2018

Study information

• Verified date: April 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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, Emergency Department 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: March 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Home Based Asthma Education
4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Callaghan-Koru JA, Riekert KA, Ruvalcaba E, Rand CS, Eakin MN. Home Medication Readiness for Preschool Children With Asthma. Pediatrics. 2018 Sep;142(3). pii: e20180829. doi: 10.1542/peds.2018-0829. Epub 2018 Aug 7. — View Citation

Eakin MN, Zaeh S, Eckmann T, Ruvalcaba E, Rand CS, Hilliard ME, Riekert KA. Effectiveness of a Home- and School-Based Asthma Educational Program for Head Start Children With Asthma: A Randomized Clinical Trial. JAMA Pediatr. 2020 Dec 1;174(12):1191-1198. — View Citation

Ruvalcaba E, Chung SE, Rand C, Riekert KA, Eakin M. Evaluating the implementation of a multicomponent asthma education program for Head Start staff. J Asthma. 2019 Feb;56(2):218-226. doi: 10.1080/02770903.2018.1443467. Epub 2018 Mar 15. — View Citation

Sadreameli SC, Riekert KA, Matsui EC, Rand CS, Eakin MN. Family Caregiver Marginalization is Associated With Decreased Primary and Subspecialty Asthma Care in Head Start Children. Acad Pediatr. 2018 Nov - Dec;18(8):905-911. doi: 10.1016/j.acap.2018.04.135. Epub 2018 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool	The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control.	Baseline, 3, 6, 9 and 12 months
Secondary	Total Number of Emergency Department (ED) Visits [Child]	Aggregate number of ED visits for asthma in past 90 days for all participants.	Baseline, 3, 6, 9 and 12 months
Secondary	Total Number of Hospitalizations [Child]	Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants.	Baseline and 12 months