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

University of Michigan

Status: Completed

Conditions: Childhood Asthma

Treatments: Other: Air Filter; Other: Air Filter and Air Conditioner; Behavioral: Community Health Worker Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00839046

R01ES014566 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 3 patient groups

1 Community Health Worker Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Community Health Worker Intervention

2 Air Filter

Experimental group

Description:

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.

Treatment:

Other: Air Filter

3 Air Filter and Air Conditioner

Experimental group

Description:

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).

Treatment:

Other: Air Filter and Air Conditioner