July 28, 2021

The Patient-Centered Outcomes Research Institute (PCORI) has announced that it has awarded the Wake Forest School of Medicine and the UNC Gillings School of Global Public Health a $29.9 million grant to help stroke survivors prevent a second stroke by controlling blood pressure.

Between 70 and 80 percent of people who have had a stroke have high blood pressure. This is a major cause of public health concern because high blood pressure is the greatest contributing factor to recurrent stroke. It also contributes to heart attacks and death in stroke survivors.

Dr. Wayne Rosamond

Dr. Wayne Rosamond

Blood pressure, however, is controllable, which is why a study team led by Professor Wayne Rosamond, PhD, and Assistant Professor Sara Jones Berkeley, PhD, of the Department of Epidemiology is collaborating with the Wake Forest School of Medicine on the new PCORI-funded clinical trial to test two different, multi-faceted and evidence-based ways to achieve healthy blood pressure in the first six months after a stroke.

Study participants will be randomized to either an Intensive Tailored Telehealth Management (ITTM) or Intensive Clinic Management (ICM) intervention. The ITTM intervention involves monitoring blood pressure at home through use of a Bluetooth-enabled blood pressure cuff, individualized health care coaching and remote clinical care, while the ICM intervention occurs in-person, with frequent blood pressure monitoring and clinical care. Stroke survivors and doctors can use the results to determine which method could lead to the best individual outcomes.

“Using telehealth was necessary during the COVID-19 pandemic,” said Cheryl Bushnell, MD, stroke division chief and professor of neurology at the Wake Forest School of Medicine. “And we believe telehealth could be an effective strategy for managing patient risk factors, specifically lowering blood pressure to targets that ultimately reduce the risk of recurrent stroke and cardiovascular events.”

Rosamond notes that “this study leverages advances in technology to enhance remote patient-clinician interaction around the common problem of blood pressure management that could have an impact on clinical practice of stroke care, as well as other conditions.”

Jones adds that “this study will help inform decisions for stroke survivors and providers about managing blood pressure after stroke. In particular, we want to identify optimal approaches to care in vulnerable groups that have either been underrepresented in other trials or are at high risk. These include older adults, African Americans and individuals with cognitive or physical disabilities.”

This new study is an extension of a previous research collaboration between Wake Forest and UNC on post-acute stroke care, the COMprehensive Post-Acute Stroke Services Study (COMPASS). The team at the Wake Forest School of Medicine, led by Bushnell, will serve as the clinical center. The Gillings School team has received $8.2 million of the award to lead the data coordinating center. The Gillings School team will include Assistant Professor Matthew Psioda, PhD, senior biostatistician and director of innovative trials at the Collaborative Studies Coordinating Center in the Department of Biostatistics.

Multiple clinic sites across the “Stroke Belt” — states in the Southeast with high rates of stroke — will participate in the study, including UNC Medical Center, Duke University Medical Center, Medical University of South Carolina, Health Sciences South Carolina, Vanderbilt University Medical Center, Mayo Clinic Florida, University of Alabama Hospital and Erlanger Health. After a preliminary feasibility phase, the trial is expected to run for five years.

Contact the UNC Gillings School of Global Public Health communications team at sphcomm@unc.edu.

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