A Community-based Participatory Research (CBPR) Intervention for Childhood Asthma Using Air Filters and Air Conditioners (CAAA)

July 20, 2017 updated by: Toby Lewis, University of Michigan

A Community Based Participatory Research Intervention for Childhood Asthma Using Air Filters and Air Conditioners

The burden of childhood asthma is borne disproportionately by children living in poverty and in urban centers, many of whom are from communities of color and are at greater risk for environmental exposures. Given the complex interaction of physical and social environmental factors on childhood asthma, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach. Community Action Against Asthma is a long standing CBPR partnership in Detroit, Michigan, composed of representatives from community-based organizations, health and human service agencies, and academia. All members of the partnership have been actively involved in the development of the CBPR project proposed here. The specific aims are: 1) to test the efficacy of air filters (AFs) separately and when combined with air conditioners (ACs) to reduce exposure to particulate matter (PM), over and above a standard community health worker home visit (standard) intervention; 2) to test the association between any reduction in PM exposure through the use of AFs separately and when combined with ACs over and above a standard intervention and health outcomes in children with asthma; 3) to elucidate the causal pathways by which any intervention-related improvements in children's asthma-related health status is occurring. One hundred and fifty households in Detroit, Michigan with at least one child with mild persistent or moderate to severe persistent asthma will be enrolled to participate in the study. Households will be randomly assigned to one of three groups: a standard household intervention (or control) group; an AF only intervention group; or an AF+AC intervention group. Extensive health and exposure measures will be undertaken during the course of the 12 -month intervention. Given the role of PM in children's asthma-related health and the higher concentrations of PM in microenvironments, there is a need to test the efficacy and efficiency of novel approaches to reducing indoor air pollutants. Doing so using a CBPR approach will enhance the relevance and ultimately the success of this proposed research.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For the proposed study we will conduct a randomized controlled trial (RCT) comparing a standard community health worker home visit intervention (the standard intervention) to an Air Filter(AF) only intervention that adds the use of an AF in the child's bedroom to the standard intervention (AF only intervention) and an Air Filter(AF)+ Air Conditioner (AC) intervention that adds the use of an AF and AC in the child's bedroom to the standard intervention (AF+AC intervention) (Figure 1). We will test whether the addition of AFs (and, in the warmer months, ACs) to the standard intervention, as compared to the standard intervention will: (1) further lower children's exposure to PM (Specific Aims 1a, 1b), and (2) further improve asthma-related health status of children (Aims 2a, 2b). One hundred and fifty Detroit households with at least one child aged 6 to 12 with symptoms consistent with persistent asthma (mild, moderate, or severe) will be enrolled in the study . Following collection of baseline data, households will be randomly assigned to receive one of three interventions: the standard household intervention, the AF only intervention, or the AF+AC intervention. Participants assigned to the AF only intervention group will receive AFs at the start of the 12-month intervention (Summer/Fall 2008). Those assigned to the AF+AC intervention group will receive AFs at the start of the intervention period but ACs will not be in place during the first summer of the intervention, but will be installed in June 2009 prior to the second summer of the intervention (Figure 2). Data will be collected across all seasons (Fall 2008 through Winter 2009) which will enable us to evaluate directly the exposure and health outcome effects (Specific Aims 1a and 2a, respectively) of the addition of AFs alone to the standard intervention as well as the exposure and health outcome effects of the AFs augmented by ACs (Aims 1b, 2b). This design will also allow for comparisons, adjusted for any changes in the exposure and health status of the intervention groups, of the combined effect of the AC and AF to that of the AF alone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2029
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Residents of EastSide or Southwest Detroit
  • child in the family between age of 6-12 with responses to the screening questionnaire consistent with known or probable persistent (mild, moderate, or severe) asthma

Exclusion Criteria

  • the family participated in our previous intervention study in Detroit
  • the family experiences continuous homelessness during the period of enrollment;
  • the child spends fewer than 80% of nights at the primary household during the school year
  • the child has a physical or mental handicap that would preclude successful completion of the child survey and spirometry.
  • the child spends fewer than 28 consecutive nights (4 weeks) during the summer (i.e., June, July, and August) at the primary household
  • the family is monolingual in a language other than English or Spanish;
  • the electrical wiring of the house is inadequate for use of the air filter/air conditioner (AF/AC)
  • the home lacks a closable door to the room where the child usually sleeps
  • there is already an existent window AC unit in the room where the child usually sleeps
  • the window in the room where the child usually sleeps will not support the addition of a window AC unit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1 Community Health Worker Intervention
This is the active control group, which all 150 participants will receive. It consists of visits from trained community health workers, who will provide asthma education, as well as provision of equipment and supplies to reduce indoor environmental exposures for asthma. These will include: vacuum cleaners, mattress and pillow covers, cleaning supplies.
Behavioral: Community Health Worker Intervention
The Community Health Worker (CHW) intervention consists of visits by CHWS to help families reduce children's exposure to common asthma triggers (allergens and irritants) in the indoor environment. The content of the CHW visits and the materials distributed will follow NHLBI Expert Panel Report 2 recommendations. Each household will receive 6 visits over a 12-month period in which the CHW will provide education on environmental triggers (e.g., reduction of dust mites, cockroaches, cat and dog dander, and environmental tobacco smoke); materials including vacuum cleaners with HEPA filters, mattress and pillow covers, and cleaning supplies; social support to the caregivers; and, if indicated, referrals to other services.
Other Names:
  • community health workers
Experimental: 2 Air Filter
The 50 families in the Air Filter Arm will receive an air filter in addition to the standard community health worker intervention. The Air Filter will be installed right after baseline measurements in the home.
Other: Air Filter
Fifty households will receive an Air Filter, in addition to receiving the standard community health worker intervention. These households will receive a HEPA room AF (Whirlpool 510 or equivalent), a relatively high capacity unit that can be quietly operated. Similar to other studies the filter will be placed in the room where the child sleeps. The HEPA AF will be installed at the beginning of the intervention period.
Experimental: 3 Air Filter and Air Conditioner
Fifty families will be assigned to the "Air Filter and Air Conditioner" Arm. In addition to the standard community health worker intervention, they will receive an air filter and an air conditioner (for the warmer months).
Other: Air Filter and Air Conditioner
Fifty households will receive the air filter and the air conditioner, in addition to receiving the standard community health worker intervention. The air filter will be installed at the beginning of the intervention, after baseline measurement. In the spring of the year (2009), a small window AC unit (Whirlpool Designer Style ACQ058MM or equivalent) will also be installed in the room where the child sleeps.
Other Names:
  • Air Conditioner
  • Air Filter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Improved Lung Function in Children with Asthma
Time Frame: End of one year of intervention
End of one year of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Reduced Particulate Matter (PM) in the home of the children with asthma
Time Frame: End of one year intervention
End of one year intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Environmental Health Sciences (NIEHS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Toby C Lewis, MD, University of Michigan School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01ES014566 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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