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Completed

NCT Number: NCT00094276

Intervention for 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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facilitated Asthma Communication Intervention (FACI)

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

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.

Primary outcomes

  1. Symptom-free days

    Time frame: Measured at baseline, 6 months and 12 months

Secondary outcomes

  1. Health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits)

    Time frame: Measured at baseline, 6 months and 12 months

  2. Asthma medications

    Time frame: Measured at baseline, 6 months and 12 months

  3. Parent asthma-related quality of life

    Time frame: Measured at baseline, 6 months and 12 months

  4. Parent asthma management practices

    Time frame: Measured at baseline, 6 months and 12 months

  5. Cost-effectiveness

    Time frame: Measured at 12 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Improving Asthma Care for Minority Children in Head Start

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2004
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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