Particulate Reduction Education in City Homes (PREACH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00466024
First received: April 25, 2007
Last updated: May 28, 2010
Last verified: March 2009

April 25, 2007
May 28, 2010
October 2006
February 2009   (final data collection date for primary outcome measure)
The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up.
Complete list of historical versions of study NCT00466024 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Particulate Reduction Education in City Homes
Particulate Reduction Education in City Homes (PREACH)

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Asthma
  • Behavioral: Health Coach and HEPA Air cleaners
    Health Coach for ETS reduction in home and 2 HEPA air cleaners
    Other Name: Behavior and HEPA
  • Behavioral: Health Coach and HEPA air cleaners
    Behavioral training and 2 HEPA air cleaners
    Other Name: Behavior and HEPA
  • Experimental: 1
    Health coach and 2 HEPA air cleaners
    Interventions:
    • Behavioral: Health Coach and HEPA Air cleaners
    • Behavioral: Health Coach and HEPA air cleaners
  • Active Comparator: 2
    Standard asthma education and 2 HEPA air cleaners
    Intervention: Behavioral: Health Coach and HEPA air cleaners
  • Active Comparator: 3
    Standard asthma education and delayed receipt of 2 HEPA air cleaners
    Intervention: Behavioral: Health Coach and HEPA air cleaners
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
June 2010
February 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00466024
001673, P01 R826724
Yes
Arlene Butz, Johns Hopkins University
Johns Hopkins University
  • Environmental Protection Agency (EPA)
  • National Institute of Environmental Health Sciences (NIEHS)
Principal Investigator: Arlene M Butz, ScD, RN Johns Hopkins University
Johns Hopkins University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP