Study to track benefits of compliance intervention
Study to track benefits of compliance intervention
Effects of habit training, problem solving sought
One of the main reasons people who live outside of a medication-controlled setting are failing HIV treatment is lack of adherence to their prescribed treatment regimen. Results of an upcoming 4½-year study may give caregivers new tools for increasing compliance rates.
Judith A. Erlen, PhD, RN, associate professor at the University of Pittsburgh School of Nursing, has received a grant from the National Institutes of Health’s National Institute of Nursing Research (NINR) to test the effects of habit training, problem solving, and intervention on patient adherence to protease inhibitors.
Erlen, who also is associate director of the Center for Research in Chronic Disorders and an Associate Professor in the Center for Medical Ethics at the University of Pittsburgh School of Nursing, says the current study plan is for researchers to deliver a 12-week telephone intervention followed by a 12-week maintenance program, then follow subjects for an additional six months. Adherence will be defined as taking medications within one hour before or after the prescribed time.
The purpose of the study is to determine if there will be sustaining effects of the intervention over the year’s time. Erlen’s group will collect baseline data at the end of the three-month intervention period, again following the maintenance program, and finally at one year. She has received funding for the study and expects to begin recruiting about 220 subjects in early February.
The Center for Research in Chronic Disorders is an NINR-sponsored center. "Through the center, we’ve advanced the science in quality of life," Erlen says. "We’re looking at adherence, functional status, and cognitive functioning, and we’re looking at the various phenomena across populations. We’ve done some previous work with quality of life and hope to move forward with these studies, building the kind of measures we want into them. It’s a unique opportunity for those of us who are doing research to be able to look at not only what we’re doing in our own particular population [but] to learn if other chronic populations have similar or different kinds of problems and outcomes.
"This will be a very systematic, structured kind of intervention, first teaching subjects how to develop a habit and then teaching them how to deal with their problems related to taking their medication," Erlen says. "Other studies have been done that have used a similar approach for habit training and problem solving, but the maintenance piece has been the piece that has not been done in the way we’re going to do it."
The study will look at two different outcomes of adherence: quality of life (a subjective measure) and the clinical measures of viral load, CD4 count, number of opportunistic infections patients have had, and whether or not they have been hospitalized. "People can be, at least by all laboratory indicators, doing very poorly, with a high viral load and low CD4’s, and yet they’ll tell you that their quality of life is fine," Erlen says. "You need to have that whole picture in order to understand something about what the patient’s health is and their quality of life and their ability to function."
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