Particulate Reduction Education in City Homes

NCT ID: NCT00466024

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-06-30

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 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Health coach and 2 HEPA air cleaners

Group Type: EXPERIMENTAL

Health Coach and HEPA Air cleaners

Intervention Type: BEHAVIORAL

Health Coach for ETS reduction in home and 2 HEPA air cleaners

Health Coach and HEPA air cleaners

Intervention Type: BEHAVIORAL

Behavioral training and 2 HEPA air cleaners

2

Standard asthma education and 2 HEPA air cleaners

Group Type: ACTIVE_COMPARATOR

Health Coach and HEPA air cleaners

Intervention Type: BEHAVIORAL

Behavioral training and 2 HEPA air cleaners

3

Standard asthma education and delayed receipt of 2 HEPA air cleaners

Group Type: ACTIVE_COMPARATOR

Health Coach and HEPA air cleaners

Intervention Type: BEHAVIORAL

Behavioral training and 2 HEPA air cleaners

Interventions

Health Coach and HEPA Air cleaners

Health Coach for ETS reduction in home and 2 HEPA air cleaners

Intervention Type: BEHAVIORAL

Health Coach and HEPA air cleaners

Behavioral training and 2 HEPA air cleaners

Intervention Type: BEHAVIORAL

Other Intervention Names

Behavior and HEPA; Behavior and HEPA

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Environmental Protection Agency (EPA)

FED

Sponsor Role: collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Arlene M. Butz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arlene M Butz, ScD, RN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

References

Butz AM, Matsui EC, Breysse P, Curtin-Brosnan J, Eggleston P, Diette G, Williams D, Yuan J, Bernert JT, Rand C. A randomized trial of air cleaners and a health coach to improve indoor air quality for inner-city children with asthma and secondhand smoke exposure. Arch Pediatr Adolesc Med. 2011 Aug;165(8):741-8. doi: 10.1001/archpediatrics.2011.111.

Reference Type: DERIVED

PMID: 21810636 (View on PubMed)

Other Identifiers

P01 R826724

Identifier Type: -

Identifier Source: secondary_id

001673

Identifier Type: -

Identifier Source: org_study_id