Ignite Creation Date:
2024-05-06 @ 12:52 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01676896
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2012-08-24
Brief Title:
Asthma in Central Texas Project
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Enhancing Childrens and Parents Asthma Management
Status:
COMPLETED
Status Verified Date:
2015-04
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:
Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve childrens asthma self-management asthma knowledge metered dose inhaler skill asthma severity and parents asthma management and access to care In this competing continuation the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention an in-school attention-control intervention or an alternate intervention-delivery format of a single 55-hour asthma day camp The tri-ethnic sample will be composed of 320 Mexican-American African-American and White rural school-aged children grades 2-5 who have asthma and their parents In addition the investigators propose adding a non-invasive measure of chronic airway inflammation exhaled nitric oxide to assess the impact of changes in asthma management on airway inflammation Families will be followed for a full year with data collection at baseline and at 1-month 4-months and 7-months after the intervention to assess improvement in childrens asthma morbidity asthma severity airway inflammation family asthma management and quality of life Hypotheses H Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements but greater improvements than the Attention-Control group inH11 their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment H12 office visits ED visits and hospitalizations for asthma and absenteeism for the study year Time 4 when compared to the pre-study year Time 1 and H14 Parents in the intervention arms will demonstrate sustained improvements in asthma caregivers quality of life QOL0 from the pre-study year Time 1 to the end of the study year Time 4 measurement when compared to the Attention-Control group
Detailed Description:
Families are recruited at the beginning of the school year Time 1 October-November parents consent and child assent obtained and baseline data collected in fall The intervention is provided in December-January Follow-up data are collected at February Time 2 April Time 3 and August Time 4
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 |
|---|---|---|---|
| R01NR007770 | NIH | None | httpsreporternihgovquickSearchR01NR007770 |