search
Back to results

Particulate Reduction Education in City Homes (PREACH)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Health Coach and HEPA Air cleaners
Health Coach and HEPA air cleaners
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Asthma, persistent, children, particulates, ETS

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Health coach and 2 HEPA air cleaners

Standard asthma education and 2 HEPA air cleaners

Standard asthma education and delayed receipt of 2 HEPA air cleaners

Outcomes

Primary Outcome Measures

The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up.

Secondary Outcome Measures

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.

Full Information

First Posted
April 25, 2007
Last Updated
August 31, 2015
Sponsor
Johns Hopkins University
Collaborators
Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00466024
Brief Title
Particulate Reduction Education in City Homes
Acronym
PREACH
Official Title
Particulate Reduction Education in City Homes (PREACH)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, persistent, children, particulates, ETS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Health coach and 2 HEPA air cleaners
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard asthma education and 2 HEPA air cleaners
Arm Title
3
Arm Type
Active Comparator
Arm Description
Standard asthma education and delayed receipt of 2 HEPA air cleaners
Intervention Type
Behavioral
Intervention Name(s)
Health Coach and HEPA Air cleaners
Other Intervention Name(s)
Behavior and HEPA
Intervention Description
Health Coach for ETS reduction in home and 2 HEPA air cleaners
Intervention Type
Behavioral
Intervention Name(s)
Health Coach and HEPA air cleaners
Other Intervention Name(s)
Behavior and HEPA
Intervention Description
Behavioral training and 2 HEPA air cleaners
Primary Outcome Measure Information:
Title
The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene M Butz, ScD, RN
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21810636
Citation
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. Erratum In: Arch Pediatr Adolesc Med. 2011 Sep;165(9):791.
Results Reference
derived

Learn more about this trial

Particulate Reduction Education in City Homes

We'll reach out to this number within 24 hrs