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

NCT00839046 | Completed DMC

• 1 other identifier: R01ES014566
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Asthma

Keywords

Pediatric Asthma; Air Filters; Indoor Particulate Matter

Outcome Measures

Primary Outcomes (1)

• Improved Lung Function in Children with Asthma

  End of one year of intervention

Secondary Outcomes (1)

• Reduced Particulate Matter (PM) in the home of the children with asthma

  End of one year intervention

Study Arms (3)

1 Community Health Worker Intervention

ACTIVE COMPARATOR

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

2 Air Filter

EXPERIMENTAL

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

3 Air Filter and Air Conditioner

EXPERIMENTAL

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

Interventions

Community Health Worker Intervention BEHAVIORAL

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.

Also known as: community health workers

1 Community Health Worker Intervention

Air Filter OTHER

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.

2 Air Filter

Air Filter and Air Conditioner OTHER

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.

Also known as: Air Conditioner, Air Filter

3 Air Filter and Air Conditioner

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109-2029, United States

Location

MeSH Terms

Interventions

Community Health Workers; Air Filters

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Study Officials

• Toby C Lewis, MD

  University of Michigan School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 9, 2009
• Study Start: August 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

US (1)