Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217906
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2005-09-19
Brief Title:
A Asthma Early Intervention in Asthma Management
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
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 project will evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents pre-school children and Head Start staff
Detailed Description:
BACKGROUND
While increased asthma morbidity and mortality have been observed across all ethnicities results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children Elementary school-based asthma education programs have shown promise in improving asthma management and reducing asthma morbidity in this high-risk population however the fastest growing asthma risk is associated with children young than six By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change To date no research has examined the impact of early intervention for asthma management in low-income high-risk children
DESIGN NARRATIVE
Head Start sites will be randomized to either a minimal intervention control group or the A Asthma early intervention program designed to educate and assist Head Start teachers and family service coordinators to optimize classroom management of asthma educate facilitate and reinforce appropriate parental medical and behavioral management of asthma and instruct model and reinforce early asthma knowledge and age-appropriate skills for preschool age children
The primary outcome that the study was designed to evaluate Head Start absencesdays enrolled determined by review of Head Start attendance records
The secondary outcomes specified in the protocol are health care utilization emergency department visits hospitalizations primary care visits asthma symptoms restricted activity symptom-free days day and nighttime symptoms asthma medications parents asthma-related quality of life and parent child and teacher asthma knowledge and management practices
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
While increased asthma morbidity and mortality have been observed across all ethnicities results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children Elementary school-based asthma education programs have shown promise in improving asthma management and reducing asthma morbidity in this high-risk population however the fastest growing asthma risk is associated with children young than six By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change To date no research has examined the impact of early intervention for asthma management in low-income high-risk children
DESIGN NARRATIVE
Head Start sites will be randomized to either a minimal intervention control group or the A Asthma early intervention program designed to educate and assist Head Start teachers and family service coordinators to optimize classroom management of asthma educate facilitate and reinforce appropriate parental medical and behavioral management of asthma and instruct model and reinforce early asthma knowledge and age-appropriate skills for preschool age children
The primary outcome that the study was designed to evaluate Head Start absencesdays enrolled determined by review of Head Start attendance records
The secondary outcomes specified in the protocol are health care utilization emergency department visits hospitalizations primary care visits asthma symptoms restricted activity symptom-free days day and nighttime symptoms asthma medications parents asthma-related quality of life and parent child and teacher asthma knowledge and management practices
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R18HL063333 | NIH | None | httpsreporternihgovquickSearchR18HL063333 |