Intervention for Improving Asthma Care for Minority Children in Head Start

NCT ID: NCT00094276

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-06-30

Brief Summary

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.

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.

Conditions

Asthma; Lung Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI)

Group Type: EXPERIMENTAL

Facilitated Asthma Communication Intervention (FACI)

Intervention Type: BEHAVIORAL

A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.

Breathmobile intervention

Intervention Type: BEHAVIORAL

A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.

2

FACI intervention

Group Type: ACTIVE_COMPARATOR

Facilitated Asthma Communication Intervention (FACI)

Intervention Type: BEHAVIORAL

A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.

3

Breathmobile intervention

Group Type: ACTIVE_COMPARATOR

Breathmobile intervention

Intervention Type: BEHAVIORAL

A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.

4

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia S. Rand

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01HL073833-01

Identifier Type: NIH

Identifier Source: secondary_id

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168

Identifier Type: -

Identifier Source: org_study_id