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Ellen O'Brien
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October 16, 2003

Daily Monitoring and Reporting of Weight and
Symptoms by Heart Failure Patients Using an Electronic Scale Lowers Mortality Rates, Study Finds

(Philadelphia, PA) -- Patients with advanced heart failure who reported daily to health-care professionals any changes in weight or symptoms associated with the illness had significantly lower mortality rates than their unmonitored peers, according to a national study led by investigators in the Heart Failure and Cardiac Transplant Program at the University of Pennsylvania Medical Center.

The findings are published this week in the American Heart Journal.

"The findings were a surprise," said Lee R. Goldberg, MD, MPH, Assistant Professor of Medicine in Penn's School of Medicine and principal investigator for the study. "We set out to determine whether the rate of hospitalization for patients who reported their weight and symptoms to health-care personnel on a daily basis might be lower than the rate for unmonitored patients. Instead, we found the hospitalization rates were essentially the same for both groups -- but there was a striking disparity in their mortality rates over the period of the study."

Over six months, the nurse-monitored group sustained 11 deaths, while the unmonitored group sustained 26 deaths -- a 56 percent difference in mortality rates. Goldberg said the impact on mortality was demonstrated despite "aggressive medical management for both patient groups," and it held true for patients of heart transplant centers as well as community medical practices.

"Guidelines for the Management of Heart Failure," recently issued jointly by the American College of Cardiology and the American Heart Association, make daily weight monitoring the cornerstone for the medical management of patients with advanced heart failure. But until Goldberg's study, there had been no prospective,
randomized clinical trial designed to evaluate the effectiveness of such monitoring.

The study followed nearly 300 patients at eight cardiac transplant centers and eight community-based cardiology medical practices. All patients received standard medical care; 138 patients were also assigned to use the AlereNet daily monitoring system (manufactured by Alere Medical, Incorporated, of Reno, NV).

Patients in the AlereNet group relied on a technology system that included an electronic scale and personalized response mechanism tied into their home telephone line. They were instructed to weigh themselves and to answer a set of five questions tailored to their individual symptoms twice each day. The information was sent to a control center and reviewed by nurses once daily over the course of the study.

Patients in the standard care group were advised to weigh themselves daily and keep a log of weight gains and losses, and they were instructed to contact their personal physician about weight increases above a prescribed amount or about any worsening symptoms. They were also asked to bring their weight log with them to the study's regularly scheduled cardiologist visits.

"We are not certain what caused the disparity in mortality rates," Goldberg said. "But the sole difference in the two groups appears to be the daily monitoring by trained nurses in the AlereNet group, which means those patients may have been more likely to benefit from rapid medical intervention."

The study was funded by Alere Medical, Incorporated.
Others who collaborated with Goldberg in the study are: John D. Piette, PhD, of the Veterans Administration Center for Practice Management and Outcomes Research, and the University of Michigan, Ann Arbor, MI; Marine Norine Walsh, MD, of Indiana University and St. Vincent's Hospital of Indianapolis, IN; Theodore A. Frank, MD, of the Sanger Clinic, Charlotte, NC; Brian E. Jaski, MD, of the San Diego Cardiac Center, Sharp Memorial Hospital, San Diego, CA; Andrew L. Smith, MD, of Emory University Division of Cardiology; Atlanta, GA; Raymond Rodriquez, MD, of Chestnut Hill Cardiology, Flourtown, PA; Donna M. Mancini, MD, of Columbia University, New York, NY; Laurie A. Hopton, RN, BSN, of Penn; John Orav, PhD, of Brigham and Women's Hospital Department of Medicine; and Evan Loh, MD, of Wyeth Ayerst Research, Philadelphia, PA, and medical investigators at the study sites.

For a printer friendly version of this release, click here.

###

Editor's Note:
Dr. Goldberg has no financial interest in Alere Medical Incorporated.

Ms. Hopton has no financial interest in Alere Medical Incorporated.

PENN Medicine is a $2.2 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System (created in 1993 as the nation’s first integrated academic health system).

Penn’s School of Medicine is ranked #2 in the nation for receipt of NIH research funds; and ranked #4 in the nation in U.S. News & World Report’s most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

Penn Health System consists of four hospitals (including its flagship Hospital of the University of Pennsylvania, consistently rated one of the nation’s “Honor Roll” hospitals by U.S. News & World Report), a faculty practice plan, a primary-care provider network, three multispecialty satellite facilities, and home health care and hospice.



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