Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426634
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2007-01-24
Brief Title:
Children With Asthma in New Orleans After Hurricane Katrina
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Head-Off Environmental Asthma in Louisiana
Status:
COMPLETED
Status Verified Date:
2016-08-30
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 examine whether exposure to the increased levels of mold and other allergens in New Orleans post-Hurricane Katrina affect symptoms in children with asthma It will also determine if having an asthma counselor AC can reduce a child s asthma symptoms in this setting An AC helps the families in the study obtain appropriate health care medicines and social services for their asthmatic child and instructs them about avoiding allergens and ridding allergens from the home
Children between 4 and 12 years of age living in Orleans Parish or surrounding areas impacted by flooding who have moderate to severe asthma may be eligible for this study
Parents provide a family medical history and information about the child s asthma symptoms medications and medical history The children undergo the following procedures
Medical examination and blood tests
Spirometry for children 6 and older or peak flow for children under 6 test For spirometry the child wears a nose clip and breathes into a mouthpiece attached to a machine that measures how fast air moves out of the child s lungs For the peak flow meter test the child blows into a plastic tube after taking a deep breath
Allergy skin testing 24 common allergens are applied to the arm by little pricks or scratches and the skin is observed for reactions to the allergens
Study staff visit the participants homes three times during the 1-year study to test for moisture mold and other allergens After the first visit families are randomly assigned to one of two groups Group 1 participants attend two educational group sessions about asthma and then three individual sessions An AC visits the home one time during the study to instruct the family on how to use supplies provided to reduce allergens in the home Group 2 participants have an individual special teaching meeting with the AC at the end of the study After the meeting the AC visits the home to instruct the family on use of the supplies
Families are surveyed by phone every 3 months during the study to answer questions about the child s asthma attacks medicines used doctor visits school days missed or work days missed to care for the child At the end of the study the child has a final medical examination blood test and breathing test
Children between 4 and 12 years of age living in Orleans Parish or surrounding areas impacted by flooding who have moderate to severe asthma may be eligible for this study
Parents provide a family medical history and information about the child s asthma symptoms medications and medical history The children undergo the following procedures
Medical examination and blood tests
Spirometry for children 6 and older or peak flow for children under 6 test For spirometry the child wears a nose clip and breathes into a mouthpiece attached to a machine that measures how fast air moves out of the child s lungs For the peak flow meter test the child blows into a plastic tube after taking a deep breath
Allergy skin testing 24 common allergens are applied to the arm by little pricks or scratches and the skin is observed for reactions to the allergens
Study staff visit the participants homes three times during the 1-year study to test for moisture mold and other allergens After the first visit families are randomly assigned to one of two groups Group 1 participants attend two educational group sessions about asthma and then three individual sessions An AC visits the home one time during the study to instruct the family on how to use supplies provided to reduce allergens in the home Group 2 participants have an individual special teaching meeting with the AC at the end of the study After the meeting the AC visits the home to instruct the family on use of the supplies
Families are surveyed by phone every 3 months during the study to answer questions about the child s asthma attacks medicines used doctor visits school days missed or work days missed to care for the child At the end of the study the child has a final medical examination blood test and breathing test
Detailed Description:
This document presents the protocol for conducting the Head-off Environmental Asthma in Louisiana HEAL study in New Orleans Louisiana The goal of the HEAL study is to implement and test an Asthma Counselor AC intervention program that addresses the multidimensional impact of hurricane Katrina on children with asthma in New Orleans HEAL is a prospective controlled trial in which children will be randomly assigned to one of two treatment groups Group 1 children will receive an AC intervention focused on case management adherence to medications and education on allergen avoidance The responsibilities of the AC in this study are enhanced relative to previous initiatives such as the National Cooperative Inner City Asthma Study NCICAS AC intervention to also provide families with education aimed at reducing mold allergens and moisture in their homes and materials to aid this effort dehumidifiers and HEPA air filters Since 90 of children with asthma in New Orleans are sensitive to dust allergens established allergen control measures will be incorporated into the AC intervention as well Group 2 children will receive a high quality standard of care based on the National Asthma Education and Prevention Program NAEPP-NIH guidelines An abbreviated AC intervention will be provided to children in Group 2 at the conclusion of the study Both treatments will be administered over a 12-month period during which the children in both groups will receive an extensive clinical evaluation at baseline and 12-months and three environmental home evaluations focused on moisture mold and other allergens In addition to monitoring the effectiveness of the AC at environmental remediation education the environmental home evaluations will also allow some characterization of the relationships between allergens post-Katrina environmental exposures and asthma morbidity
In addition to the enhanced AC intervention a separate school based survey will be administered to a sample population of children to examine asthma prevalence and assess living conditions and stress levels that may have been influenced by hurricane Katrina The survey population will consist of a sample of the families of Orleans Parish school children stratified by age schools and geographic area of the Parish The results of the survey in combination with the results of the AC intervention will give us an overview of the extent and severity of the asthma problem in post hurricane Katrina New Orleans
The HEAL project is a collaborative multi-institutional research project conducted by the Tulane University School of Public Health and Tropical Medicine and the New Orleans Department of Health To support those efforts Rho Inc will provide for coordination of data and study activities
In addition to the enhanced AC intervention a separate school based survey will be administered to a sample population of children to examine asthma prevalence and assess living conditions and stress levels that may have been influenced by hurricane Katrina The survey population will consist of a sample of the families of Orleans Parish school children stratified by age schools and geographic area of the Parish The results of the survey in combination with the results of the AC intervention will give us an overview of the extent and severity of the asthma problem in post hurricane Katrina New Orleans
The HEAL project is a collaborative multi-institutional research project conducted by the Tulane University School of Public Health and Tropical Medicine and the New Orleans Department of Health To support those efforts Rho Inc will provide for coordination of data and study activities
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 |
|---|---|---|---|
| 07-E-N068 | None | None | None |