Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094276
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2004-10-15
Brief Title:
Intervention for Improving Asthma Care for Minority Children in Head Start
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Improving Asthma Care for Minority Children in Head Start
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 caregivers 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 caregiverPCP communication intervention designed to facilitate communication between parents and PCPs about a childs 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 ie 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 childs asthma and in reducing asthma morbidity
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 caregivers 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 caregiverPCP communication intervention designed to facilitate communication between parents and PCPs about a childs 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 ie 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 childs asthma and in reducing asthma morbidity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL073833-01 | NIH | None | httpsreporternihgovquickSearchR01HL073833-01 |