Intervention for Improving Asthma Care for Minority Children in Head Start

Improving Asthma Care for Minority Children in Head Start

This study will evaluate two interventions that are designed to reduce asthma morbidity and improve asthma care of children in Head Start in urban Baltimore.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Asthma
• Intervention / Treatment: Behavioral: Facilitated Asthma Communication Intervention (FACI); Behavioral: Breathmobile intervention

Detailed Description

BACKGROUND:

Asthma-related morbidity and mortality are disproportionately high among low-income African American children. The effects of asthma are particularly harsh in very young children and their families, resulting in high rates of emergency department care, hospitalization, decreased quality of life, and the risk of fatal asthma. Research suggests that the contributing factors to this high morbidity include under-use of asthma primary preventive care, sub-optimal medical management, and inappropriate asthma management behaviors. Despite the importance of early and regular asthma preventive care for children, this goal has proved elusive. Head Start programs offer an ideal venue for accessing high-risk, low-income preschool children and improving asthma morbidity. The study will test the hypothesis that removing barriers to preventive asthma care and facilitating communication between parents and primary care providers (PCP) are necessary prerequisites to optimally influence caregiver's asthma management practices. The study will remove barriers by the use of Breathmobile, a community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods. In addition, the study will evaluate a caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.

DESIGN NARRATIVE:

This two times two modified factorial study design will compare the following in their effectiveness in reducing asthma morbidity and improving asthma management: a Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI); a FACI alone; the Breathmobile intervention alone; or a control group. A total of 360 Head Start students ages 2 to 6 with symptomatic doctor-diagnosed asthma will be recruited. The primary study outcome measure will be the number of symptom-free days over a period of 12 months. Secondary outcomes include health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits), asthma medications, parent asthma-related quality of life, parent asthma management practices, and cost-effectiveness. The study will test the hypothesis that a FACI combined with the Breathmobile intervention will be the most effective in improving parent and PCP management of the child's asthma and in reducing asthma morbidity.

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of asthma or reactive airway disease (RAD) OR
• Experienced asthma symptoms within 1 month prior to study entry
• Treated for asthma in the emergency department within 6 months prior to study entry
• Asthma symptoms include day or nighttime wheezing, shortness of breath and cough, or use of rescue medicine (e.g., albuterol or ventolin)

Exclusion Criteria:

• Currently participating in another asthma education research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 4; Control group
Experimental: 1; Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI)	Behavioral: Facilitated Asthma Communication Intervention (FACI); A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.; Behavioral: Breathmobile intervention; A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.
Active Comparator: 2; FACI intervention	Behavioral: Facilitated Asthma Communication Intervention (FACI); A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
Active Comparator: 3; Breathmobile intervention	Behavioral: Breathmobile intervention; A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptom-free days	Measured at baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits)	Measured at baseline, 6 months and 12 months
Asthma medications	Measured at baseline, 6 months and 12 months
Parent asthma-related quality of life	Measured at baseline, 6 months and 12 months
Parent asthma management practices	Measured at baseline, 6 months and 12 months
Cost-effectiveness	Measured at 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Cynthia S. Rand, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: October 15, 2004
• First Submitted That Met QC Criteria: October 14, 2004
• First Posted (Estimate): October 15, 2004

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases; Asthma
• Other Study ID Numbers: 168; R01HL073833-01 (U.S. NIH Grant/Contract)