Reducing Asthma Morbidity In High Risk Minority Preschool Children

NCT01519453 | Completed Results DMC

• 2 other identifiers: NA_00046455HL-107223
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Preschool; Health Disparities; Implementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total Number of Emergency Department (ED) Visits [Child]

  Baseline, 3, 6, 9 and 12 months

• Total Number of Hospitalizations [Child]

  Baseline and 12 months

Study Arms (2)

Home Based Asthma Education

EXPERIMENTAL

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

Behavioral: Home Based Asthma Education

Control

NO INTERVENTION

There is no control arm specific intervention

Interventions

Home Based Asthma Education BEHAVIORAL

4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education

Home Based Asthma Education

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Enrolled in another pulmonary research study
• Sibling enrolled in study

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related Publications (5)

• 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.

  PMID: 30087197 BACKGROUND

• 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.

  PMID: 29543493 BACKGROUND

• 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.

  PMID: 29730244 BACKGROUND

• 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.

  PMID: 33016987 RESULT

• 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.

  PMID: 34774736 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Michelle Eakin
• Organization: Johns Hopkins School of Medicine

meakin1@jhmi.edu

410-550-0487

Study Officials

• Cynthia Rand, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 27, 2012
• Study Start: September 1, 2011
• Primary Completion: November 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 11, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)