Intervention for Improving Asthma Care for Minority Children in Head Start

Asthma Clinical Trial

Official title:

Improving Asthma Care for Minority Children in Head Start

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094276
• Other study ID #: 168
• Secondary ID: R01HL073833-01
• Status: Completed
• Phase: N/A
• First received: October 15, 2004
• Last updated: April 24, 2018
• Start date: September 2004
• Est. completion date: June 2009

Study information

• Verified date: April 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom-free days		Measured at baseline, 6 months and 12 months
Secondary	Health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits)		Measured at baseline, 6 months and 12 months
Secondary	Asthma medications		Measured at baseline, 6 months and 12 months
Secondary	Parent asthma-related quality of life		Measured at baseline, 6 months and 12 months
Secondary	Parent asthma management practices		Measured at baseline, 6 months and 12 months
Secondary	Cost-effectiveness		Measured at 12 months