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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Based Asthma Education
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Preschool, Health Disparities, Implementation

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home Based Asthma Education

Control

Arm Description

Families will receive 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker

There is no control arm specific intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total Number of Emergency Department (ED) Visits [Child]
Aggregate number of ED visits for asthma in past 90 days for all participants.
Total Number of Hospitalizations [Child]
Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants.

Full Information

First Posted
January 24, 2012
Last Updated
April 22, 2021
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01519453
Brief Title
Reducing Asthma Morbidity In High Risk Minority Preschool Children
Acronym
ABC-HS
Official Title
Reducing Asthma Morbidity in High Risk Minority Preschool Children (Asthma Basic Care (ABC) at Head Start)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Preschool, Health Disparities, Implementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Based Asthma Education
Arm Type
Experimental
Arm Description
Families will receive 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker
Arm Title
Control
Arm Type
No Intervention
Arm Description
There is no control arm specific intervention
Intervention Type
Behavioral
Intervention Name(s)
Home Based Asthma Education
Intervention Description
4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education
Primary Outcome Measure Information:
Title
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
Description
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.
Time Frame
Baseline, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Total Number of Emergency Department (ED) Visits [Child]
Description
Aggregate number of ED visits for asthma in past 90 days for all participants.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Total Number of Hospitalizations [Child]
Description
Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Rand, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not be sharing individual participant data with other researchers
Citations:
PubMed Identifier
30087197
Citation
Callaghan-Koru JA, Riekert KA, Ruvalcaba E, Rand CS, Eakin MN. Home Medication Readiness for Preschool Children With Asthma. Pediatrics. 2018 Sep;142(3):e20180829. doi: 10.1542/peds.2018-0829. Epub 2018 Aug 7.
Results Reference
background
PubMed Identifier
29543493
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.
Results Reference
background
PubMed Identifier
29730244
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.
Results Reference
background
PubMed Identifier
33016987
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. doi: 10.1001/jamapediatrics.2020.3375.
Results Reference
result
PubMed Identifier
34774736
Citation
Lu MA, Eckmann T, Ruvalcaba E, McQuaid EL, Rand CS, Riekert KA, Eakin MN. Family management of asthma in Head Start preschool children. Ann Allergy Asthma Immunol. 2022 Feb;128(2):178-183. doi: 10.1016/j.anai.2021.11.002. Epub 2021 Nov 10.
Results Reference
derived

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Reducing Asthma Morbidity In High Risk Minority Preschool Children

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