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Sponsors and Collaborators: |
Johns Hopkins University Environmental Protection Agency (EPA) National Institute of Environmental Health Sciences (NIEHS) |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00466024 |
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).
Condition | Intervention | Phase |
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Asthma |
Behavioral: Health Coach and HEPA Air cleaners Behavioral: Health Coach and HEPA air cleaners |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Particulate Reduction Education in City Homes (PREACH) |
Estimated Enrollment: | 150 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Health coach and 2 HEPA air cleaners
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Behavioral: Health Coach and HEPA Air cleaners
Health Coach for ETS reduction in home and 2 HEPA air cleaners
Behavioral: Health Coach and HEPA air cleaners
Behavioral training and 2 HEPA air cleaners
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2: Active Comparator
Standard asthma education and 2 HEPA air cleaners
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Behavioral: Health Coach and HEPA air cleaners
Behavioral training and 2 HEPA air cleaners
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3: Active Comparator
Standard asthma education and delayed receipt of 2 HEPA air cleaners
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Behavioral: Health Coach and HEPA air cleaners
Behavioral training and 2 HEPA air cleaners
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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 ETS/Indoor 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 ETS/Indoor 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 reduce/eliminate their child's exposure to ETS in the home. The intervention is based on the social cognitive theory that utilizes behavior modification techniques (e.g., 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 PM2.5 over the 6 month follow-up. Secondary outcomes include ETS reduction behavior change (i.e. 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.
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
An eligible child will be defined as:
Household:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Arlene M Butz, ScD, RN | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Arlene Butz ) |
Study ID Numbers: | 001673, P01 R826724 |
Study First Received: | April 25, 2007 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00466024 History of Changes |
Health Authority: | United States: Institutional Review Board |
Asthma persistent children particulates ETS |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |