AsthmaPhase 3PREACHNCT00466024
Particulate Reduction Education in City Homes
A Phase 3 study testing Health Coach and HEPA Air cleaners in people with Asthma, run by Johns Hopkins University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Health Coach and HEPA Air cleaners
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Being tested
- Health Coach and HEPA Air cleaners
- Keywords
- Asthma, persistent, children, particulates, ETS
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Coach and HEPA Air cleanersBehavioural
Also called Behavior and HEPA
Health Coach for ETS reduction in home and 2 HEPA air cleaners
Health Coach and HEPA air cleanersBehavioural
Also called Behavior and HEPA
Behavioral training and 2 HEPA air cleaners
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Health coach and 2 HEPA air cleaners Receives: Behavioral: Health Coach and HEPA Air cleaners |
| 2 | Active comparator | Standard asthma education and 2 HEPA air cleaners Receives: Behavioral: Health Coach and HEPA air cleaners |
| 3 | Active comparator | Standard asthma education and delayed receipt of 2 HEPA air cleaners Receives: Behavioral: Health Coach and HEPA air cleaners |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionFeb 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Arlene M. Butz, Johns Hopkins University
- Investigators
- Arlene M Butz, ScD, RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466024
- Sponsor's protocol ID
- 001673
- Other IDs
- P01 R826724
- Acronym
- PREACH
- Status last verified
- Mar 2009
- First submitted
- 25 Apr 2007
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21810636
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Particulate Reduction Education in City Homes (PREACH)
- ClinicalTrials.gov ID
- NCT00466024
- Acronym / sponsor ID
- PREACH / 001673
- Conditions
- Asthma
- Keywords
- Asthma, persistent, children, particulates, ETS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Oct 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Health Coach and HEPA Air cleanersHealth coach and 2 HEPA air cleaners |
| 2 | Active comparator | Behavioral: Health Coach and HEPA air cleanersStandard asthma education and 2 HEPA air cleaners |
| 3 | Active comparator | Behavioral: Health Coach and HEPA air cleanersStandard asthma education and delayed receipt of 2 HEPA air cleaners |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- An eligible child will be defined as:
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Coach and HEPA Air cleanersAlso: Behavior and HEPAHealth Coach for ETS reduction in home and 2 HEPA air cleaners | Behavioural | 1 |
| Health Coach and HEPA air cleanersAlso: Behavior and HEPABehavioral training and 2 HEPA air cleaners | Behavioural | 1, 2, 3 |
Primary outcome
The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up.
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
- Derived from this study: PubMed 21810636Butz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene M Butz, ScD, RN principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Health Coach and HEPA Air cleaners in people with Asthma, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.