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Clinical Trials: Asthma

by Jeff Worley

Illustration of inhalerIt takes many researchers some time—years maybe—to find their niche. In Pat Burkhart's case, her research focus found her.

"Twenty-four years ago my son, Kevin, was diagnosed with asthma when he was two years old," says Burkhart, an assistant professor in UK's College of Nursing. She began to read everything she could about childhood asthma. This intensive study led her to a Ph.D. in nursing with a research focus on child asthma and to recently being certified as an asthma educator by the American Lung Association.

According to the Centers for Disease Control and Prevention, asthma is the most prevalent chronic condition among children in the United States, affecting over eight million children, including 70,000 in Kentucky. And here's an even scarier statistic: while death rates for many diseases are falling, the mortality rates for children age 19 and younger with asthma increased by 78 percent between 1980 and 1993.

Burkhart says that while there's wide agreement on the genetic predisposition for asthma, it's tough to definitively pin down other causes.

"Some epidemiologists say that children are experiencing heavy-duty allergens because our houses are so airtight. Then there's the older theory about keeping your kids from close contact with other kids, such as in day-care centers, because they'll pick up more colds and develop airway inflammation that can lead to asthma."

The problem is, she says, these theories have tended to change over the years. "Here's another theor: since we've used antibiotics extensively, maybe childrens' immune systems aren't strong enough to combat bacteria and viruses." She adds that having pets in the household also used to be taboo, but now some clinicians think kids who are exposed to animals early tend not to be allergic to them later in life because, through such contact, children build up the necessary antibodies.

Despite the confusion about what causes asthma, Burkhart says that blame for increased rates in morbidity and mortality among children with the disease may be a lack of early intervention, lack of knowledge regarding self-management, and non-adherence to prescribed treatment regimes. In a clinical trial funded by the National Institute of Nursing Research at NIH, Burkhart is working to help resolve these issues.

Photo of Patricia BurkhartPatricia Burkhart in the College of Nursing holds an electronic peak-flow monitor, which records objective data about a child's breathing rates. She is heading up a clinical trial to evaluate different ways of teaching kids with persistent asthma to self-manage their condition at home.

Her two-year trial will involve 86 children ages 7 to 11 with persistent asthma. As principal investigator, she will evaluate different ways of teaching kids to manage their asthma at home using a device that electronically gathers data.

What Burkhart hopes to achieve through an educational and behavioral intervention is to increase children's adherence to daily peak expiratory flow rate (PEFR) monitoring. Peak-flow monitoring is integral to asthma self-management for patients with persistent asthma in order to assess the existence and severity of airflow obstruction. However, there are no published studies on how to promote children's adherence to daily self-monitoring.

"Peak-flow meters are simple, handheld monitors," Burkhart explains, "that can detect airway obstruction, often before any appearance of clinical signs." If a child blows into it and the number falls during the day, this indicates that the airways are starting to constrict, even before coughing, wheezing or shortness of breath occur. The child can intervene early to prevent a major asthmatic episode. During the trial, each child will use an electronic peak-flow meter that records the date, time and peak-flow value. It also includes a self-report symptom and medication diary.

Burkhart was the first nurse researcher to use a microprocessor-based peak-flow measurement instrument. "This is the centerpiece for this clinical trial and a huge advance over the less accurate self-report asthma diaries that have been traditionally used. Now, objective data can be downloaded to a computer and gathered electronically," she says.

In this study the intervention group will receive intense asthma education. The control group will get the usual care, she says. "Typically, the health-care provider will simply say, 'Here's your peak-flow meter. We'd like you to blow into it every day. Record your numbers in a diary and send it in to us,'" Burkhart says, adding that adherence issues regarding regular peak-flow monitoring are generally not addressed.

The intervention group (children and their parents) will have five one-on-one sessions with a pediatric nurse, while the control group will have three one-on-one sessions during a 16-week period. Both groups will be asked to perform daily peak-flow monitoring at home and to record their peak-flow values, asthma symptoms, and medications in an asthma diary.

"The first thing we do with the intervention group is to teach kids what their peak-flow numbers mean," Burkhart says. "We have them blow into the meter in the morning and in the evening for two to three weeks so we can determine their 'personal best'—their highest number—to get a baseline. Then we determine their 'zones,' which are color-coded, based on their personal best value." She teaches children to think of their zones in terms of a traffic light.

An action plan is put in place so that the child and parent know exactly what to do for each zone. "Green means your asthma is under control. Yellow means take action. It indicates the child may need to add a bronchodilator medication and to increase the amount of inhaled corticosteroids in order to control the symptoms. If the peak flow values drop into the red zone, we teach the children that they should head to the nearest emergency department."

Burkhart's own son, she says, has diligently used the meter and worked hard all his life to manage his asthma well and prevent asthma attacks. "He's 26 now and living in New York City," she says. "He's doing great—he recently ran in the marathon there and crossed the finish line with his family cheering him on."

For information on how your child can participate in the Children with Asthma Study, call 859/323-6874.

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