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

Childhood Asthma Clinical Trial

— CAAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839046
• Other study ID #: R01ES014566
• Secondary ID: R01ES014566
• Status: Completed
• Phase: N/A
• First received: February 5, 2009
• Last updated: July 20, 2017
• Start date: August 2007
• Est. completion date: October 2010

Study information

• Verified date: July 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma

Intervention

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:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved Lung Function in Children with Asthma		End of one year of intervention
Secondary	Reduced Particulate Matter (PM) in the home of the children with asthma		End of one year intervention