Particulate Reduction Education in City Homes

Asthma Clinical Trial

— PREACH  

Official title:

Particulate Reduction Education in City Homes (PREACH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466024
• Other study ID #: 001673
• Secondary ID: P01 R826724
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2007
• Last updated: August 31, 2015
• Start date: October 2006
• Est. completion date: June 2010

Study information

• Verified date: March 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• An eligible child will be defined as:

• Age 6-12 years

• Doctor's diagnosis of asthma

• Currently having persistent asthma, defined as asthma symptoms or use of quick reliever asthma medication > 2 days/week in the last 2 weeks or use of daily controller asthma medication in past 2 weeks based on parent report.

• Reside in eligible household at least 5 days per week

Household:

• Located in Baltimore

• Housing an eligible child

• Housing an English speaking family

• Housing at least one smoker, who smokes 5 or more cigarettes per day. Smoking in the car will be recorded, but if ETS exposure is limited to the car, the household is not eligible.

• Having working electricity and no major structural damage.

• Having no working air cleaner

Exclusion Criteria:

• Children will be excluded is they have other respiratory morbidity such as cystic fibrosis or bronchopulmonary dysplasia, if they smoke cigarettes, if they do not have asthma symptoms or medication use in the month before randomization

• Families living in a shelter or transitional housing will be excluded

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Health Coach and HEPA Air cleaners
Health Coach for ETS reduction in home and 2 HEPA air cleaners
• Health Coach and HEPA air cleaners
Behavioral training and 2 HEPA air cleaners

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up.		6 months	No
Secondary	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.		6 months	No