Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466024
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2007-04-25
Brief Title:
Particulate Reduction Education in City Homes
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Particulate Reduction Education in City Homes PREACH
Status:
COMPLETED
Status Verified Date:
2009-03
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:
PREACH
Brief Summary:
The purpose of this study is to conduct a randomized controlled trial of the efficacy of a combination of HEPA room air cleaners plus an ETS reduction behavior training as compared to either HEPA air cleaners plus standard asthma education or delayed HEPA air cleaners and standard asthma education control group
Detailed Description:
150 children aged 6-12 years who reside in Baltimore and have a smoker in the household are to be enrolled in this study All children will be randomized into three groups HEPA air cleaners plus ETSIndoor particulate behavior management HEPA air cleaners and a standard asthma education and a standard asthma education group with delayed HEPA filter use The HEPA air cleaner plus ETSIndoor particulate behavior management intervention group will receive four home visits by a health coach to assess motivation for parental behavior change and then assist the parent to reduceeliminate their childs exposure to ETS in the home The intervention is based on the social cognitive theory that utilizes behavior modification techniques eg modeling reinforcement self-monitoring feedback and rehearsal to change health behaviors Families in this group and the HEPA air cleaner only group will receive two HEPA air cleaners to use over the 6-month follow-up period and three home visits for standard asthma education Use of air cleaners will be electronically monitored to determine level or dose of air cleaning used by families The standard asthma education group delayed HEPA Filter group will receive three home visits to deliver basic asthma education All children receive a baseline home inspection 7-day home PM exposure monitoring home dust allergen collection skin testing urine cotinine spirometry serum eosinophilia and exhaled NO testing Caregivers of each child will be interviewed at baseline and at the 6-month follow-up regarding ETS reduction behaviors in the home symptom frequency asthma control other environmental exposures and health care utilization outcomes The primary outcome for this study is reduction in PM10 and PM25 over the 6 month follow-up Secondary outcomes include ETS reduction behavior change ie smoker is smoking outside of home child not sitting with smoker reduction in number of household smokers symptom free days and health care utilization measures If successful this intervention could have significant clinical and public health applications for pediatric asthma management in children with persistent asthma and high ETS home exposure
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 |
|---|---|---|---|
| P01 R826724 | None | None | None |