Intervention for Improving Asthma Care for Minority Children in Head Start
Primary Purpose
Asthma, Lung Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facilitated Asthma Communication Intervention (FACI)
Breathmobile intervention
Sponsored by
About this trial
This is an interventional prevention trial for Asthma
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
Sites / Locations
- Johns Hopkins University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
No Intervention
Arm Label
1
2
3
4
Arm Description
Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI)
FACI intervention
Breathmobile intervention
Control group
Outcomes
Primary Outcome Measures
Symptom-free days
Secondary Outcome Measures
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
Cost-effectiveness
Full Information
NCT ID
NCT00094276
First Posted
October 15, 2004
Last Updated
April 24, 2018
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00094276
Brief Title
Intervention for Improving Asthma Care for Minority Children in Head Start
Official Title
Improving Asthma Care for Minority Children in Head Start
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Lung Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
336 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI)
Arm Title
2
Arm Type
Active Comparator
Arm Description
FACI intervention
Arm Title
3
Arm Type
Active Comparator
Arm Description
Breathmobile intervention
Arm Title
4
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Facilitated Asthma Communication Intervention (FACI)
Intervention Description
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
Intervention Name(s)
Breathmobile intervention
Intervention Description
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 Outcome Measure Information:
Title
Symptom-free days
Time Frame
Measured at baseline, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits)
Time Frame
Measured at baseline, 6 months and 12 months
Title
Asthma medications
Time Frame
Measured at baseline, 6 months and 12 months
Title
Parent asthma-related quality of life
Time Frame
Measured at baseline, 6 months and 12 months
Title
Parent asthma management practices
Time Frame
Measured at baseline, 6 months and 12 months
Title
Cost-effectiveness
Time Frame
Measured at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia S. Rand
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
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Intervention for Improving Asthma Care for Minority Children in Head Start
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