Intervention for Improving Asthma Care for Minority Children in Head Start
Improving Asthma Care for Minority Children in Head Start
2 other identifiers
interventional
336
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Sep 2004
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 15, 2004
CompletedFirst Posted
Study publicly available on registry
October 15, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedApril 25, 2018
April 1, 2018
4.8 years
October 15, 2004
April 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Symptom-free days
Measured at baseline, 6 months and 12 months
Secondary Outcomes (5)
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
Study Arms (4)
1
EXPERIMENTALBreathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI)
2
ACTIVE COMPARATORFACI intervention
3
ACTIVE COMPARATORBreathmobile intervention
4
NO INTERVENTIONControl group
Interventions
A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Currently participating in another asthma education research study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia S. Rand
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2004
First Posted
October 15, 2004
Study Start
September 1, 2004
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
April 25, 2018
Record last verified: 2018-04