Environmental Factor, November 2006, National Institute of Environmental Health Sciences
NIEHS to Help New Orleans HEAL
By Eddy Ball
In August 2005, the world watched as Hurricane Katrina devastated New Orleans and surrounding areas, displaced over half the city's population and drove an already disadvantaged population into crisis mode. NIEHS helped New Orleans then, and the institute plans to help again with an elegantly designed clinical intervention study set to begin recruiting participants in November. The 30-month collaborative Head-off Environmental Asthma in Louisiana (HEAL) study offers scientists an unprecedented opportunity to provide immediate help for New Orleans children with persistent or uncontrolled asthma, as well as refine and develop intervention protocols for treating the condition effectively at the community level.
NIEHS Director for Translational Research William Martin, M.D., explained that the study builds upon what has been learned from a series of earlier studies of asthma in inner-city environments to improve the quality of intervention. "In NIH terms, this project is type two translational research," explained Martin. "It involves taking knowledge that we have learned from basic science, clinical studies and public health studies and applying it in practice to a community."
NIEHS Health Scientist Administrator Pat Chulada, Ph.D., has taken the lead in designing this study, in conjunction with health care professionals and scientists from the Tulane University School of Public Health and Tropical Medicine, the New Orleans Department of Health and private sector companies Constella Group and Rho, Inc., NIEHS-funded scientists will launch a major initiative to recruit, evaluate and test a study population of children with asthma. According to Chulada, researchers are especially interested in determining how effective outreach and educational efforts can be in moderating asthmatic children's response to exposures and elucidating the genetic/environmental interactions that exacerbate the condition.
Chulada emphasized that the goal of HEAL is to implement and test an expanded Asthma Counselor (AC) intervention model, which includes a comprehensive educational role in addition to conventional case management duties. The intervention model can then be replicated in conditions similar to those in New Orleans to enhance quality and continuity of care. Put simply, the assumption is that if the interventions work in New Orleans with its extreme damage and antigen-nurturing environment by reducing symptom occurrence, the enhanced AC model will be effective almost anywhere.
Using a network of screening and referral sources, HEAL will recruit and enroll at least 450 children, aged four to twelve years, for the study. In addition to age requirements, participants must meet three other inclusion criteria: uncontrolled or persistent asthma, current long-term asthma control therapy, and a parent or legal guardian willing to provide written informed consent.
The intake process will include questionnaires and interviews, clinical examinations, training on use of peak flow meters, and testing for pulmonary functioning and allergic reactions (prick skin testing). Participating laboratories will test blood samples for IgE and IgG antibodies, with a portion of the blood archived for future genetic testing.
The environmental intervention component of HEAL will involve visits to the homes of participants. Technicians will perform visual inspection, a home environment survey, air sampling, and indoor dust and allergen collection. The study will tailor AC intervention according to each participant family's risk assessment and needs, providing training, supplies and allergen-abatement equipment to improve the home environment.
Chulada explained that the approximately 450 participants will be divided into two groups, which will both receive referrals for access to high-quality care for their condition. In addition, one group will receive AC intervention. Researchers will examine mean maximum symptom day difference between the groups as endpoints, testing their hypothesis that the combined intervention will improve patient outcomes. At the end of the study, children in group two (the control group with no AC) will receive intervention similar to that provided to group one participants. Parents of children in both groups will participate in follow-up phone surveys for asthma morbidity.
An adjunct component of HEAL will involve two rounds of school surveys administered to approximately 1,500 families with children in New Orleans schools, public and private. The survey will help analysts assess post-Katrina living conditions and stress levels of the families and establish the prevalence of children with asthma.